Stage IV Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab With or Without IMC-A12 in Patients With Advanced Non-squamous, Non-small Cell Lung Cancer
Verified date | May 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase II trial studies how well carboplatin, paclitaxel, and bevacizumab (CPB) work when given with or without cixutumumab in treating patients with non-small cell lung cancer that is stage IV or has come back (recurrent). Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Other types of monoclonal antibodies, such as cixutumumab, may find tumor cells and help kill them. It is not yet known whether giving more than one drug (combination chemotherapy) together with bevacizumab is more effective when given with or without cixutumumab in treating patients with non-small cell lung cancer.
Status | Terminated |
Enrollment | 175 |
Est. completion date | November 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed with non-squamous, non-small cell lung cancer (NSCLC) - Advanced NSCLC defined as either recurrent disease after prior radiation or surgery or stage IV (M1a or M1b) based on the TNM staging system (American Joint Committee on Cancer [AJCC] 2009) - Measurable disease as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). All sites of disease (of target and non-target disease sites) must be obtained within 4 weeks prior to randomization - A head computed tomography (CT) or magnetic resonance imaging (MRI) required within 4 weeks prior to randomization - Prior radiation therapy (RT) is allowed if it has been completed 3 weeks prior to randomization and patient has recovered from any adverse events related to RT - Brain metastases are allowed, provided they have been treated with surgery and/or radiotherapy, the patient is neurologically stable, and repeat brain imaging shows no progression in the brain; at least 6 weeks should have elapsed from the time of craniotomy and at least 4 weeks from radiotherapy - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Absolute neutrophil count (ANC) = 1500/mm³ - Platelet count = 100,000/mm³ - Total bilirubin within institutional upper limit of normal (ULN) - Serum creatinine = 1.5 x ULN - Fasting blood glucose within normal range (fasting < 120 mg/dL or below ULN) - Alkaline phosphatase (ALP) = 3 x ULN - Aspartate transaminase (AST) and alanine transaminase (ALT) = 3 x ULN - Urine dipstick must be = 0-1+ within 2 weeks (14 days) of randomization; if urine dipstick result is > 1+, a calculation of urine protein creatinine (UPC) ratio is required; patients must have a UPC ratio < 1.0 to participate in the study - Neuropathy, if present at baseline, must be = Common Terminology Criteria for Adverse Events (CTCAE) grade 1 - Patients with a history of hypertension must be well-controlled (= 150/90) on a stable regimen of anti-hypertensive therapy - Women of childbearing potential and sexually active males should use an accepted and effective method of contraception while on treatment and for 3 months thereafter Exclusion Criteria: - Prior chemotherapy or biologic/molecular targeted therapy for advanced NSCLC. Prior chemotherapy and/or biological/molecular targeted therapy as part of initial potentially curative therapy (one regimen of induction and/or adjuvant and/or concurrent chemoradiotherapy) was allowed provided it had been completed 1 year or more prior to randomization - Prior treatment with IMC-A12 or another insulin-like growth factor 1 receptor (IGF-1R) inhibitor - Patients on therapeutic anticoagulation; patient's international normalized ratio (INR) must be = 1.5 or partial thromboplastin time (PTT) = upper limits of normal within 2 weeks prior to randomization to be eligible; prophylactic anticoagulation of venous access devices is allowed provided the above criteria have been met - Prior allergic reaction to compounds of chemical or biologic composition similar to those of IMC-A12 - Hypersensitivity to any component of bevacizumab - Poorly controlled diabetes mellitus - History of other invasive malignancies unless there is no active disease and all treatment has been completed = 3 years prior to randomization; patients with history of in-situ malignancies and curatively resected nonmelanomatous skin cancer are eligible - History of thrombotic or hemorrhagic disorders - History of bleeding diathesis or coagulopathy - = grade 2 bleeding or any bleeding requiring intervention within 4 weeks prior to randomization - History of gross hemoptysis (defined as = 1/2 teaspoon of bright red blood) - Any of the following within 6 months prior to randomization: - Abdominal fistula - Gastrointestinal perforation - Intra-abdominal abscess - Previous myocardial infarction - History of any central nervous system (CNS) cerebrovascular ischemia - New York Heart Association (NYHA) > class II congestive heart failure or severe heart failure - Unstable or symptomatic angina pectoris - History of stroke - Significant vascular disease - Symptomatic peripheral vascular disease - Ongoing, serious cardiac arrhythmia requiring medication at time of randomization - Ongoing, active infection or ongoing fever at the time of randomization or any co-existing medical condition, psychiatric illness or limitations that would interfere with compliance of study requirements - History of hypertensive crisis or hypertensive encephalopathy - Any of the following within 4 weeks prior to randomization: a serious non-healing wound, ulcer, bone fracture, or major surgical procedure - Anticipated major surgical procedure(s) during the course of the study - Receiving daily treatment with aspirin (> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function for chronic conditions; patients must not be receiving treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal); if patient was receiving any of the following: aspirin (> 325 mg/day), NSAID, and/or anti-platelet drugs, patient must have discontinued its use = 1 week prior to randomization - Pregnant or breast-feeding - Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy |
Country | Name | City | State |
---|---|---|---|
United States | Summa Akron City Hospital/Cooper Cancer Center | Akron | Ohio |
United States | McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa |
United States | Michigan Cancer Research Consortium CCOP | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Fox Valley Hematology and Oncology | Appleton | Wisconsin |
United States | The Medical Center of Aurora | Aurora | Colorado |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | Sanford Clinic North-Bemidgi | Bemidji | Minnesota |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota |
United States | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Mercy Medical Center | Canton | Ohio |
United States | Mercy Hospital | Cedar Rapids | Iowa |
United States | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | West Virginia University Charleston | Charleston | West Virginia |
United States | Saint Joseph Hospital | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Columbus NCI Community Oncology Research Program | Columbus | Ohio |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Dallas VA Medical Center | Dallas | Texas |
United States | Parkland Memorial Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Colorado Cancer Research Program NCORP | Denver | Colorado |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado |
United States | Rose Medical Center | Denver | Colorado |
United States | SCL Health Saint Joseph Hospital | Denver | Colorado |
United States | Iowa Lutheran Hospital | Des Moines | Iowa |
United States | Iowa Methodist Medical Center | Des Moines | Iowa |
United States | Iowa-Wide Oncology Research Coalition NCORP | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa |
United States | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | Essentia Health Cancer Center | Duluth | Minnesota |
United States | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota |
United States | Miller-Dwan Hospital | Duluth | Minnesota |
United States | Veterans Adminstration New Jersey Health Care System | East Orange | New Jersey |
United States | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Roger Maris Cancer Center | Fargo | North Dakota |
United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
United States | Sanford Medical Center-Fargo | Fargo | North Dakota |
United States | Hunterdon Medical Center | Flemington | New Jersey |
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 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Unity Hospital | Fridley | Minnesota |
United States | Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | PinnacleHealth Cancer Center-Community Campus | Harrisburg | Pennsylvania |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania |
United States | Hinsdale Hematology Oncology Associates Incorporated | Hinsdale | Illinois |
United States | Hutchinson Area Health Care | Hutchinson | Minnesota |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Allegiance Health | Jackson | Michigan |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Lakeland Regional Cancer Center | Lakeland | Florida |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Saint Mary Medical and Regional Cancer Center | Langhorne | Pennsylvania |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Saint Rita's Medical Center | Lima | Ohio |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Sky Ridge Medical Center | Lone Tree | Colorado |
United States | Longmont United Hospital | Longmont | Colorado |
United States | McKee Medical Center | Loveland | Colorado |
United States | Dean Hematology and Oncology Clinic | Madison | Wisconsin |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Cancer Center of Kansas - McPherson | McPherson | Kansas |
United States | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | The Hospital of Central Connecticut | New Britain | Connecticut |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Rutgers New Jersey Medical School | Newark | New Jersey |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut |
United States | Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc | Wisconsin |
United States | Alegent Health Lakeside Hospital | Omaha | Nebraska |
United States | Ottumwa Regional Health Center | Ottumwa | Iowa |
United States | Paoli Memorial Hospital | Paoli | Pennsylvania |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
United States | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Saint Joseph Mercy Port Huron | Port Huron | Michigan |
United States | Southern Ohio Medical Center | Portsmouth | Ohio |
United States | Pottstown Memorial Medical Center | Pottstown | Pennsylvania |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | Swedish American Hospital | Rockford | Illinois |
United States | SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Mercy Medical Center-Sioux City | Sioux City | Iowa |
United States | Saint Luke's Regional Medical Center | Sioux City | Iowa |
United States | Siouxland Regional Cancer Center | Sioux City | Iowa |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Avera McKennan Hospital and University Health Center | Sioux Falls | South Dakota |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Geisinger Medical Group | State College | Pennsylvania |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | North Suburban Medical Center | Thornton | Colorado |
United States | Charlotte Hungerford Hospital Center for Cancer Care | Torrington | Connecticut |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Waukesha Memorial Hospital | Waukesha | Wisconsin |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Reading Hospital | West Reading | Pennsylvania |
United States | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Main Office | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
United States | Wichita NCI Community Oncology Research Program | Wichita | Kansas |
United States | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Minnesota Oncology and Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
United States | Main Line Health NCORP | Wynnewood | Pennsylvania |
United States | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Argiris, A., Lee, J., Leach, J.W., Schiller, J.H.: Safety analysis of a phase II randomized trial of carboplatin (C), Paclitaxel (P), bevacizumab (B) with or without cixutumumab (CX) in patients (pts) with advanced non-squamous, non-small cell lung cancer
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) | Progression-free survival was defined as the time from randomization to progression or death without documentation of progression. For cases without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurs within 3 months following the date last known progression-free, in which case the death was counted as a failure. Progression was evaluated using RECIST 1.1 criteria and defined as: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. OR Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. |
Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years | |
Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to death or date last known alive. | Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years | |
Secondary | Proportion of Patients With Objective Response | Objective response was evaluated using the RECIST 1.1 criteria. Objective response includes complete response (CR) and partial response (PR). Objective response is defined as disappearance of all target lesions or at least a 30% decrease in the sum of the diameters of target lesions. In addition, non-target lesions do not meet the criteria for disease progression and no new lesions were observed. |
Assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry; up to 5 years |
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