A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

NCT ID: NCT00096993

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-09-30

Brief Summary

This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

Conditions

Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo + 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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo was provided as a single-use formulation for infusion.

Gemcitabine

Intervention Type: DRUG

Gemcitabine was provided as a solution for infusion.

Pertuzumab + gemcitabine

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

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

Gemcitabine was provided as a solution for infusion.

Pertuzumab

Intervention Type: DRUG

Pertuzumab was provided as a single-use formulation for infusion.

Interventions

Placebo

Placebo was provided as a single-use formulation for infusion.

Intervention Type: DRUG

Gemcitabine

Gemcitabine was provided as a solution for infusion.

Intervention Type: DRUG

Pertuzumab

Pertuzumab was provided as a single-use formulation for infusion.

Intervention Type: DRUG

Other Intervention Names

Gemzar; rhuMAb 2C4

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia Patton, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Univ. of Alabama at Birmingham

Birmingham, Alabama, United States

Comprehensive Cancer Institute

Huntsville, Alabama, United States

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, United States

Arizona Cancer Center

Tucson, Arizona, United States

Alta Bates Comp. Cancer Ctr

Berkeley, California, United States

California Cancer Crae, Inc

Greenbrae, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Sutter Cancer Center

Sacramento, California, United States

Southern California Permanente Medical Group (Kaiser)

San Diego, California, United States

Sharp Healthcare

San Diego, California, United States

Norwalk Medical Group

Norwalk, Connecticut, United States

Hematology Oncology, P.C.

Stamford, Connecticut, United States

Integrated Community Oncology Network

Jacksonville, Florida, United States

Florida Hospital

Orlando, Florida, United States

Memorial Health Univ. Med. Ctr.

Savannah, Georgia, United States

St. Luke's Mountain States Tumor Institute

Boise, Idaho, United States

North Idaho Cancer Center

Coeur d'Alene, Idaho, United States

University Of Chicago

Chicago, Illinois, United States

Carle Clinic Association

Urbana, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Cancer Center of Kansas

Wichita, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Franklin Square Hospital Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Wayne State Univ. Barbara Ann Karmanos Cancer Inst.

Detroit, Michigan, United States

Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, United States

Cooper Health System

Voorhees Township, New Jersey, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Ohio State University College of Medicaine

Columbus, Ohio, United States

Pelvic Surgery Assoc.

Columbus, Ohio, United States

Oklahoma Univ. Medical Center

Oklahoma City, Oklahoma, United States

Corvallis Clinic

Corvallis, Oregon, United States

Kaiser Permanente Northwest Division

Portland, Oregon, United States

Womens and Infants Hospital

Providence, Rhode Island, United States

Northern Virginia Pelvic Surgery Assoc.

Annandale, Virginia, United States

Carilion Gyn/Onc

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

TOC3258g

Identifier Type: -

Identifier Source: org_study_id