A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Omnitarg, Cancer, Platinum-Resistant
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age >= 18 years Advanced, histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma Representative tumor specimens in paraffin blocks or at least 12 unstained slides with an associated pathology report, obtained at any time prior to entry of study for evaluation of HER2 activation Measurable disease with at least one lesion that can be accurately measured in at least one dimension (longest dimension recorded), Or: Clinically or radiologically detectable disease (e.g., ascites, peritoneal deposits, mesenteric thickening or lesions that do not fulfill RECIST for measurable disease) Platinum-resistant or refractory carcinoma Life expectancy >= 12 weeks ECOG performance status 0 or 1 LVEF >= 50%, as determined by ECHO Use of an effective means of contraception (for women of childbearing potential) Clinical laboratory test results: Granulocyte count >= 1500/uL; Platelet count >= 75,000/uL; Hemoglobin >= 9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved hematopoietic growth factors; darbopoeitin [Aranesp(R)] is permitted); Serum bilirubin <= 1.5 the ULN; Alkaline phosphatase, AST, and ALT <= 2.5 ULN (AST, ALT <= 5 ULN for subjects with liver metastasis); Serum creatinine <= 1.5 ULN; International normalized ratio (INR) <= 1.5 and activated partial thromboplastin time (aPTT) <= 1.5 ULN (except for subjects receiving anti-coagulation therapy) Exclusion Criteria: Prior treatment with gemcitabine Two or more prior regimens for the treatment of platinum-resistant disease Two or more non-platinum-containing regimens for the treatment of platinum-sensitive disease Prior treatment with experimental anti-cancer agents within 4 weeks prior to Day 1 (the day the first study treatment infusions are administered) Prior treatment with HER2 pathway inhibitors (e.g., Herceptin(R) [trastuzumab], Iressa(R) [gefitinib], Tarceva<TM> [erlotinib hydrochloride], cetuximab, GW572016) History or clinical evidence of central nervous system or brain metastases Uncontrolled hypercalcemia ( > 11.5 mg/dL) Prior exposure of > 360 mg/m^2 doxorubicin or liposomal doxorubicin, > 120 mg/m^2 mitoxantrone, or > 90 mg/m^2 idarubicin History of other malignancies within 5 years of Day 1, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, basal or squamous cell skin cancer History of serious systemic disease, unstable angina, myocardial infarction within 6 months prior to Day 1 of treatment, symptoms of CHF, or unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia [i.e., atrial fibrillation, paroxysmal supraventricular tachycardia] are eligible) Known HIV infection Pregnancy or lactation Major surgery or significant traumatic injury within 3 weeks prior to Day 1 of treatment Inability to comply with study and follow-up procedures Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
Sites / Locations
- Univ. of Alabama at Birmingham
- Comprehensive Cancer Institute
- Northwest Alabama Cancer Center
- Arizona Cancer Center
- Alta Bates Comp. Cancer Ctr
- California Cancer Crae, Inc
- Cedars-Sinai Medical Center
- University of California, Los Angeles
- Ventura County Hematology Oncology Specialists
- Sutter Cancer Center
- Southern California Permanente Medical Group (Kaiser)
- Sharp Healthcare
- Norwalk Medical Group
- Hematology Oncology, P.C.
- Integrated Community Oncology Network
- Florida Hospital
- Memorial Health Univ. Med. Ctr.
- St. Luke's Mountain States Tumor Institute
- North Idaho Cancer Center
- University Of Chicago
- Carle Clinic Association
- Indiana University
- St. Vincent Hospital
- Cancer Center of Kansas
- University of Kentucky
- Greater Baltimore Medical Center
- Franklin Square Hospital Center
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Wayne State Univ. Barbara Ann Karmanos Cancer Inst.
- Center for Cancer and Hematologic Disease
- Cooper Health System
- Carolinas Medical Center
- Ohio State University College of Medicaine
- Pelvic Surgery Assoc.
- Oklahoma Univ. Medical Center
- Corvallis Clinic
- Kaiser Permanente Northwest Division
- Womens and Infants Hospital
- Northern Virginia Pelvic Surgery Assoc.
- Carilion Gyn/Onc
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo + gemcitabine
Pertuzumab + gemcitabine
Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles