Recurrent Malignant Mesothelioma Clinical Trial
Official title:
A Phase I/Randomized Phase II Study of Cediranib (NSC#732208) Versus Placebo in Combination With Cisplatin and Pemetrexed in Chemonaive Patients With Malignant Pleural Mesothelioma
Verified date | March 2024 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase I/II trial is studying the side effects and best dose of cediranib maleate when given together with pemetrexed disodium and cisplatin and to see how well it works in treating patients with malignant pleural mesothelioma. Drugs used in chemotherapy, pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving pemetrexed disodium and cisplatin together with cediranib maleate may kill more tumor cells.
Status | Active, not recruiting |
Enrollment | 117 |
Est. completion date | March 7, 2025 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient must have histologically or cytologically confirmed diagnosis of malignant pleural mesothelioma; surgical resection must not be planned - Patients must have measurable or non-measurable disease by both RECIST and modified RECIST criteria for pleural tumors as documented by computed tomography (CT) scan; examinations for assessment of measurable disease must have been completed within 28 days prior to registration; examinations for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the RECIST 1.1 and Modified RECIST Baseline Tumor Assessment Form - Patients must not have received any prior systemic therapy (chemotherapy or other biologic therapy) for their unresectable malignant pleural mesothelioma; prior systemic chemotherapy or biologic therapy is allowed as neoadjuvant or adjuvant treatment, disease has now recurred, and all systemic treatment was completed > 6 months prior registration; prior therapy must not have included cediranib - Patients may have received prior surgery (e.g., pleurectomy, pleurodeisis) provided at least 28 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities at the time of registration; there must be no anticipated need for major surgical procedures during protocol treatment - Patients may have received prior radiation therapy provided at least 28 days have elapsed since the last treatment and patients have recovered from all associated toxicities at the time of registration - Institutions must seek additional patient consent for the banking and future use of specimens - Patient must have Zubrod performance status 0-2 - Absolute neutrophil count >= 1,500 mcl - Platelets >= 100,000/ml - Hemoglobin >= 9.0 g/dl (may be reached by transfusion) - Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) - Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN (if liver metastases are present, SGOT or SGPT must be =< 5.0 x IULN) - Serum creatinine =< 1.5 x IULN - Calculated creatinine clearance >= 60 mL/min - Urine protein must be screened by urine analysis within 28 days prior to registration; patient must not have greater than +1 proteinuria on two consecutive dipsticks taken no less than 7 days apart; however, if the first urinalysis shows no protein, then a repeat urinalysis is not required - Patient must have an electrocardiogram (ECG) performed within 42 days prior to registration; patient must not have mean corrected QT (QTc) > 500 msec (with Bazett's correction) in screening electrocardiogram, or other significant ECG abnormality, New York Heart Association (NYHA) classification III or IV; patient must not require concurrent use of drugs or biologics with proarrhythmic potential - Patient must not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine) - Patient must not have had clinically significant hemoptysis, defined as greater than 1 tablespoon of bright red blood, within one year prior to registration; although hemoptysis has not been associated with cediranib, it may be a class effect for anti-angiogenic agents and therefore a risk factor for this experimental agent - Patient must be able to swallow oral medications - Patients must not have known human immunodeficiency virus (HIV) infection - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol treatment - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years |
Country | Name | City | State |
---|---|---|---|
United States | Pali Momi Medical Center | 'Aiea | Hawaii |
United States | Queen's Cancer Center - Pearlridge | 'Aiea | Hawaii |
United States | Community Hospital of Anaconda | Anaconda | Montana |
United States | Cancer Care Center at Island Hospital | Anacortes | Washington |
United States | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan |
United States | Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Kaiser Permanente-Deer Valley Medical Center | Antioch | California |
United States | Franciscan Saint Francis Health-Beech Grove | Beech Grove | Indiana |
United States | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington |
United States | Strecker Cancer Center-Belpre | Belpre | Ohio |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Montana Cancer Consortium NCORP | Billings | Montana |
United States | Saint Vincent Frontier Cancer Center | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | OSF Saint Joseph Medical Center | Bloomington | Illinois |
United States | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
United States | Bozeman Health Deaconess Hospital | Bozeman | Montana |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Bristol Regional Medical Center | Bristol | Tennessee |
United States | Wellmont Medical Associates Oncology and Hematology-Bristol | Bristol | Tennessee |
United States | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California |
United States | Highline Medical Center-Main Campus | Burien | Washington |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Rocky Mountain Oncology | Casper | Wyoming |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | Novant Health Carolina Surgical - Randolph | Charlotte | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | Oncology Specialists of Charlotte | Charlotte | North Carolina |
United States | Southern Oncology Specialists-Charlotte | Charlotte | North Carolina |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Oncology Hematology Care Inc-Anderson | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Blue Ash | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Eden Park | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Mercy West | Cincinnati | Ohio |
United States | Clackamas Radiation Oncology Center | Clackamas | Oregon |
United States | Big Horn Basin Cancer Center | Cody | Wyoming |
United States | Billings Clinic-Cody | Cody | Wyoming |
United States | Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Columbus NCI Community Oncology Research Program | Columbus | Ohio |
United States | Columbus Oncology and Hematology Associates Inc | Columbus | Ohio |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | Mount Carmel East Hospital | Columbus | Ohio |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | The Mark H Zangmeister Center | Columbus | Ohio |
United States | Oncology Hematology Care Inc-Crestview | Crestview Hills | Kentucky |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Dayton NCI Community Oncology Research Program | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Miami Valley Hospital North | Dayton | Ohio |
United States | Beaumont Hospital - Dearborn | Dearborn | Michigan |
United States | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Heartland Cancer Research NCORP | Decatur | Illinois |
United States | Delaware Health Center-Grady Cancer Center | Delaware | Ohio |
United States | Delaware Radiation Oncology | Delaware | Ohio |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Ascension Saint John Hospital | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Prisma Health Cancer Institute - Easley | Easley | South Carolina |
United States | Swedish Cancer Institute-Edmonds | Edmonds | Washington |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Oncology Hematology Care Inc-Healthplex | Fairfield | Ohio |
United States | Weisberg Cancer Treatment Center | Farmington Hills | Michigan |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Kaiser Permanente-Fremont | Fremont | California |
United States | Kaiser Permanente-Fresno | Fresno | California |
United States | Northeast Georgia Medical Center-Gainesville | Gainesville | Georgia |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
United States | Benefis Sletten Cancer Institute | Great Falls | Montana |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Faris | Greenville | South Carolina |
United States | Prisma Health Greenville Memorial Hospital | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Prisma Health Cancer Institute - Greer | Greer | South Carolina |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Hendersonville Hematology and Oncology at Pardee | Hendersonville | North Carolina |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii |
United States | Hawaii Cancer Care Inc-Liliha | Honolulu | Hawaii |
United States | Kaiser Permanente Moanalua Medical Center | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Kuakini Medical Center | Honolulu | Hawaii |
United States | Queen's Cancer Center - Kuakini | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Novant Health Cancer Institute - Huntersville | Huntersville | North Carolina |
United States | Southern Oncology Specialists-Huntersville | Huntersville | North Carolina |
United States | Franciscan Health Indianapolis | Indianapolis | Indiana |
United States | Swedish Cancer Institute-Issaquah | Issaquah | Washington |
United States | Allegiance Health | Jackson | Michigan |
United States | MU Health Care Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | Wellmont Medical Associates Oncology and Hematology-Johnson City | Johnson City | Tennessee |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Glacier Oncology PLLC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Kadlec Clinic Hematology and Oncology | Kennewick | Washington |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Ballad Health Cancer Care - Kingsport | Kingsport | Tennessee |
United States | Wellmont Holston Valley Hospital and Medical Center | Kingsport | Tennessee |
United States | FHCC at EvergreenHealth | Kirkland | Washington |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | University of Michigan Health - Sparrow Lansing | Lansing | Michigan |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan |
United States | PeaceHealth Saint John Medical Center | Longview | Washington |
United States | Los Angeles General Medical Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | OhioHealth Mansfield Hospital | Mansfield | Ohio |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | OhioHealth Marion General Hospital | Marion | Ohio |
United States | Matthews Radiation Oncology Center | Matthews | North Carolina |
United States | Novant Health Cancer Institute - Matthews | Matthews | North Carolina |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Community Medical Center | Missoula | Montana |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Kaiser Permanente-Modesto | Modesto | California |
United States | Novant Health Cancer Institute - Mooresville | Mooresville | North Carolina |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Skagit Valley Hospital | Mount Vernon | Washington |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Newark Radiation Oncology | Newark | Ohio |
United States | Providence Newberg Medical Center | Newberg | Oregon |
United States | Southwest VA Regional Cancer Center | Norton | Virginia |
United States | Cancer Care Center of O'Fallon | O'Fallon | Illinois |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Providence Willamette Falls Medical Center | Oregon City | Oregon |
United States | Orlando Health Cancer Institute | Orlando | Florida |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Radiation Oncology of Northern Illinois | Ottawa | Illinois |
United States | Singing River Hospital | Pascagoula | Mississippi |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan |
United States | Lake Huron Medical Center | Port Huron | Michigan |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Providence Saint Vincent Medical Center | Portland | Oregon |
United States | Southern Ohio Medical Center | Portsmouth | Ohio |
United States | Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho |
United States | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Kaiser Permanente-Redwood City | Redwood City | California |
United States | Kaiser Permanente-Richmond | Richmond | California |
United States | Reid Health | Richmond | Indiana |
United States | Highlands Oncology Group - Rogers | Rogers | Arkansas |
United States | Kaiser Permanente-Roseville | Roseville | California |
United States | Kaiser Permanente - Sacramento | Sacramento | California |
United States | Kaiser Permanente-South Sacramento | Sacramento | California |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Ascension Saint Mary's Hospital | Saginaw | Michigan |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
United States | Kaiser Permanente-San Francisco | San Francisco | California |
United States | Kaiser Permanente-Santa Teresa-San Jose | San Jose | California |
United States | Kaiser Permanente San Leandro | San Leandro | California |
United States | Kaiser Permanente-San Rafael | San Rafael | California |
United States | Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho |
United States | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California |
United States | Kaiser Permanente-Santa Rosa | Santa Rosa | California |
United States | Fred Hutchinson Cancer Center | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Kaiser Permanente Washington | Seattle | Washington |
United States | Minor and James Medical PLLC | Seattle | Washington |
United States | Swedish Medical Center-Ballard Campus | Seattle | Washington |
United States | Swedish Medical Center-First Hill | Seattle | Washington |
United States | University of Washington Medical Center - Montlake | Seattle | Washington |
United States | PeaceHealth United General Medical Center | Sedro-Woolley | Washington |
United States | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Kaiser Permanente-South San Francisco | South San Francisco | California |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Evergreen Hematology and Oncology PS | Spokane | Washington |
United States | Rockwood Clinic | Spokane | Washington |
United States | Central Illinois Hematology Oncology Center | Springfield | Illinois |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Iredell Memorial Hospital | Statesville | North Carolina |
United States | Kaiser Permanente-Stockton | Stockton | California |
United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
United States | BJC Outpatient Center at Sunset Hills | Sunset Hills | Missouri |
United States | Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Kaiser Permanente Medical Center-Vacaville | Vacaville | California |
United States | Kaiser Permanente-Vallejo | Vallejo | California |
United States | Compass Oncology Vancouver | Vancouver | Washington |
United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
United States | Kaiser Permanente-Walnut Creek | Walnut Creek | California |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Wenatchee Valley Hospital and Clinics | Wenatchee | Washington |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | Southeast Clinical Oncology Research Consortium NCORP | Winston-Salem | North Carolina |
United States | Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I) | MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to one of the 3 study drugs). The following events occurring in the first cycle of treatment are considered dose limiting.
Febrile neutropenia Grade 4 neutrophil count decrease for more than 7 days' duration Grade 4 platelet count decrease Grade 3 or 4 non-hematologic toxicity (excluding alopecia) |
Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment. | |
Primary | Progression-free Survival (Phase II) | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesions, or the appearance of new lesions. | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever came first, assessed up to 5 years.Disease assessment will be repeated every 6 weeks until disease progression. | |
Secondary | Overall Survival (Phase II) | From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. | From date of registration to death.Disease assessment will be repeated every 6 weeks until disease progression. After progression, follow up will occur every 6 months for the first two years and then at the end of the third year after registration. | |
Secondary | Response Rate by RECIST1.1 (Phase II) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
All target measurable lesions must be assessed using the same techniques as baseline. |
Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years. Best response is documented for as long as the patient remains on protocol treatment. | |
Secondary | Disease Control Rate by RECIST 1.1 (Phase II) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA
All target measurable lesions must be assessed using the same techniques as baseline. |
Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control rate is documented for as long as the patient remains on protocol treatment. | |
Secondary | Response Rate by Modified RECIST (Phase II) | Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
All target measurable lesions must be assessed using the same techniques as baseline. |
Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Best response is documented for as long as the patient remains on protocol treatment. | |
Secondary | Disease Control Rate by Modified RECIST (Phase II) | Per modified RECIST for Pleural Tumors. In addition to RECIST1.1, for modified RECIST, measurements based on the sum of 6 CT cuts in the pleural perpendicular to the chest wall are applied to standard RECIST criterial (sum of 6 = one univariate diameter). Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (STA), does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA.
All target measurable lesions must be assessed using the same techniques as baseline. |
Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years.Disease control is documented for as long as the patient remains on protocol treatment. | |
Secondary | (Phase I) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. | Toxicity assessment is repeated weekly during first cycle (1cycle = 21 days), then every cycle while patient is on treatment. | |
Secondary | (Phase II) Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. | Toxicity assessment is repeated every 3 weeks while patient is on treatment. |
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