Recurrent Breast Carcinoma Clinical Trial
Official title:
Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer
Verified date | May 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 14, 2018 |
Est. primary completion date | September 9, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed diagnosis of breast cancer with diagnosis of metastatic or locally recurrent disease (locally recurrent disease should be stage IV e.g. chest wall involvement) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (Karnofsky >= 80%) - Life expectancy of > 12 weeks - Capable of understanding investigational nature, potential risks and benefits of the study and able to provide written informed consent - Negative serum pregnancy test =< 7 days of registration for women of childbearing potential: - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study therapy and for 3 months after the last dose of IMC-A12 and CCI-779 (temsirolimus) - Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately - Nursing women must be willing to discontinue nursing; NOTE: breastfeeding should be discontinued if the mother is treated with CCI-779 and IMC-A12 - Absolute neutrophil count >= 1,500/mcL - Hemoglobin >= 8.5 g/dL - Platelets >= 100,000/mcL - Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) - Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (=< 5 X institutional ULN if liver function test [LFT] elevations due to liver metastases) - Creatinine =< 1.5 X institutional ULN OR creatinine clearance >= 60 mL/min/1.73^2 for patients with creatinine > institutional ULN - Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L) - Fasting triglycerides =< 400 mg/dL (4.56 mmol/L) - Albumin >= 3.4 mg/dL - Fasting or non fasting serum glucose < 120 mg/dL - Hemoglobin A1c (HbA1c) (for all patients with a history of diabetes mellitus) < 8% - Phase I only: Any number of prior therapy regimens is allowed - Phase II only: Measurable disease is required for the Phase II portion of the study; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], x-ray) or as >= 10 mm with spiral CT scan - Phase II only: =< two and at least one prior chemotherapy regimens in the setting of metastatic or locally recurrent (stage IV chest wall involvement) disease are required Exclusion Criteria: - Phase I patients only: Patients with base line diabetes requiring oral hypoglycemics or insulin - Phase II patients only: Poorly controlled diabetes mellitus; NOTE: patients with a history of diabetes mellitus on oral hypoglycemics or insulin are allowed to participate, provided that their fasting blood glucose is < 120 mg/dL and that they are on a stable dietary or therapeutic regimen for this condition - Any of the following: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (hormonal agents are not allowed and oral contraceptives are not acceptable for contraception) - Receiving hormonal agents used for the treatment of breast cancer with the exception that premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist and subsequently progressed may, at the discretion of the treating physician, continue on the GnRH agonist - Any of the following prior therapies: - Systemic anti-cancer therapy =< 3 weeks prior to registration - Radiation therapy =< 2 weeks prior to registration - Prior invasive non-breast malignancy, except for adequately treated basal or squamous cell carcinoma of the skin or other cancer from which the patient has been disease free for >= 5 years - Known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin, and azithromycin); allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12, or temsirolimus - Prior treatment with agents targeting the insulin-like growth factor-I receptor (IGF-IR)/insulin-like growth factors (IGFs) or phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (Akt)/mechanistic target of rapamycin (mTOR) pathway - Receiving any other investigational agents or herbal preparations - Patients may not be taking oral corticosteroids except for replacement for adrenal insufficiency - Uncontrolled brain metastases; Note: brain metastases are not permitted on study unless the metastases have been treated by surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for >= 12 weeks - Known human immunodeficiency virus (HIV)-positive patients who have cluster of differentiation (CD)4 counts below the normal range or who are on anti-retroviral therapy that may interfere with the metabolism of temsirolimus - Uncontrolled intercurrent illness including, but not limited to: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Uncontrolled symptomatic cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements - Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) or any other cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer such as rifampin or St. John's wort |
Country | Name | City | State |
---|---|---|---|
United States | Hawaii Oncology Inc-Pali Momi | 'Aiea | Hawaii |
United States | Pali Momi Medical Center | 'Aiea | Hawaii |
United States | Bixby Medical Center | Adrian | Michigan |
United States | Hickman Cancer Center | Adrian | Michigan |
United States | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Randolph Hospital | Asheboro | North Carolina |
United States | Rush - Copley Medical Center | Aurora | Illinois |
United States | The Medical Center of Aurora | Aurora | Colorado |
United States | Mid Dakota Clinic | Bismarck | North Dakota |
United States | Saint Alexius Medical Center | Bismarck | North Dakota |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Boulder Community Hospital | Boulder | Colorado |
United States | Toledo Clinic Cancer Centers-Bowling Green | Bowling Green | Ohio |
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | Graham Hospital Association | Canton | Illinois |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Weiss Memorial Hospital | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
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 | John B Amos Cancer Center | Columbus | Georgia |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
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 | Samaritan North Health Center | Dayton | Ohio |
United States | Beaumont Hospital-Dearborn | Dearborn | Michigan |
United States | Heartland Cancer Research NCORP | Decatur | Illinois |
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 | Saint John Hospital and Medical Center | Detroit | Michigan |
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 | Union Hospital of Cecil County | Elkton | Maryland |
United States | Hematology Oncology Center Incorporated | Elyria | Ohio |
United States | Mercy Cancer Center-Elyria | Elyria | Ohio |
United States | Swedish Medical Center | Englewood | Colorado |
United States | Green Bay Oncology - Escanaba | Escanaba | Michigan |
United States | Eureka Hospital | Eureka | Illinois |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
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 | Fredericksburg Oncology Inc | Fredericksburg | Virginia |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Glens Falls Hospital | Glens Falls | New York |
United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
United States | Altru Cancer Center | Grand Forks | North Dakota |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | North Colorado Medical Center | Greeley | Colorado |
United States | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin |
United States | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin |
United States | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin |
United States | Cone Health Cancer Center | Greensboro | North Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Ingalls Memorial Hospital | Harvey | Illinois |
United States | Illinois CancerCare-Havana | Havana | Illinois |
United States | Mason District Hospital | Havana | Illinois |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Hawaii Cancer Care Inc-POB II | Honolulu | Hawaii |
United States | Hawaii Oncology Inc-Kuakini | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | 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 | Franciscan Health Indianapolis | Indianapolis | Indiana |
United States | Green Bay Oncology - Iron Mountain | Iron Mountain | Michigan |
United States | Allegiance Health | Jackson | Michigan |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | Nebraska Cancer Research Center | Lincoln | Nebraska |
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 | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | Mcdonough District Hospital | Macomb | Illinois |
United States | Holy Family Memorial Hospital | Manitowoc | Wisconsin |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio |
United States | Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee | Ohio |
United States | Holy Family Medical Center | Monmouth | Illinois |
United States | Illinois CancerCare-Monmouth | Monmouth | Illinois |
United States | Mercy Memorial Hospital | Monroe | Michigan |
United States | Toledo Clinic Cancer Centers-Monroe | Monroe | Michigan |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Bromenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center Foundation | Normal | Illinois |
United States | Illinois CancerCare-Community Cancer Center | Normal | Illinois |
United States | Green Bay Oncology - Oconto Falls | Oconto Falls | Wisconsin |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Alegent Health Immanuel Medical Center | Omaha | Nebraska |
United States | Alegent Health Lakeside Hospital | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | Saint Charles Hospital | Oregon | Ohio |
United States | Toledo Clinic Cancer Centers-Oregon | Oregon | Ohio |
United States | Florida Hospital Orlando | Orlando | Florida |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | Palo Alto Medical Foundation Health Care | Palo Alto | California |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | 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 | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Illinois Valley Hospital | Peru | Illinois |
United States | Valley Medical Oncology Consultants | Pleasanton | California |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Lake Huron Medical Center | Port Huron | Michigan |
United States | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon |
United States | Southern Ohio Medical Center | Portsmouth | Ohio |
United States | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | Annie Penn Memorial Hospital | Reidsville | North Carolina |
United States | Reid Health | Richmond | Indiana |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota |
United States | Saint Cloud Hospital | Saint Cloud | Minnesota |
United States | Saint Joseph Oncology Inc | Saint Joseph | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | HSHS Saint Nicholas Hospital | Sheboygan | Wisconsin |
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 | Illinois CancerCare-Spring Valley | Spring Valley | Illinois |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Green Bay Oncology - Sturgeon Bay | Sturgeon Bay | Wisconsin |
United States | Flower Hospital | Sylvania | Ohio |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | Mercy Saint Anne Hospital | Toledo | Ohio |
United States | Saint Vincent Mercy Medical Center | Toledo | Ohio |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio |
United States | Toledo Community Hospital Oncology Program CCOP | Toledo | Ohio |
United States | University of Toledo | Toledo | Ohio |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | Natalie Warren Bryant Cancer Center at Saint Francis | Tulsa | Oklahoma |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Legacy Salmon Creek Hospital | Vancouver | Washington |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado |
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 | Recommended Dose Level for Phase II Testing (RPTD) (Phase I) | The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported. Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria: Any grade 4 hematologic toxicity Hyperglycemia that cannot be stably controlled with diabetic medication Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia) |
During first course | |
Primary | Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II) | A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart. Complete Response (CR): All of the following must be true: Disappearance of all target and non-target lesions. Each target lymph node must have reduction in short axis to <1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures. The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach. |
Up to 5 years | |
Secondary | Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II) | Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be 'at least possibly related to treatment' will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported. | Up to 5 years | |
Secondary | Duration of Response (Phase II) | Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method. | Up to 5 years | |
Secondary | Progression Free Survival (PFS) (Phase II) | Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method. | Time from registration to documentation of disease progression, up to 5 years | |
Secondary | Progression Free Survival Rate | Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method. | At 6 months | |
Secondary | Survival Time (Phase II) | Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. | Time from registration to death due to any cause |
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