A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination With Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
1 other identifier
interventional
131
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Jan 2005
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2004
CompletedFirst Posted
Study publicly available on registry
November 18, 2004
CompletedStudy Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedResults Posted
Study results publicly available
June 10, 2015
CompletedJune 10, 2015
June 1, 2015
2.7 years
November 17, 2004
May 26, 2015
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.
Baseline to the end of the study (up to 1 year)
Secondary Outcomes (4)
Percentage of Participants With an Objective Response
Baseline to the end of the study (up to 1 year)
Duration of the Objective Response
Baseline to the end of the study (up to 1 year)
Percentage of Participants Free From Disease Progression at 4 Months
Baseline to Month 4
Duration of Survival
Baseline to the end of the study (up to 1 year)
Study Arms (2)
Placebo + gemcitabine
PLACEBO COMPARATORParticipants 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).
Pertuzumab + gemcitabine
ACTIVE COMPARATORParticipants 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
Interventions
Gemcitabine was provided as a solution for infusion.
Pertuzumab was provided as a single-use formulation for infusion.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (41)
Univ. of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Comprehensive Cancer Institute
Huntsville, Alabama, 35801, United States
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Alta Bates Comp. Cancer Ctr
Berkeley, California, 94704, United States
California Cancer Crae, Inc
Greenbrae, California, 94904, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
Southern California Permanente Medical Group (Kaiser)
San Diego, California, 92120, United States
Sharp Healthcare
San Diego, California, 92123, United States
Norwalk Medical Group
Norwalk, Connecticut, 06856, United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Florida Hospital
Orlando, Florida, 32804, United States
Memorial Health Univ. Med. Ctr.
Savannah, Georgia, 31404, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
Indiana University
Indianapolis, Indiana, 46202, United States
St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Wayne State Univ. Barbara Ann Karmanos Cancer Inst.
Detroit, Michigan, 48201, United States
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Cooper Health System
Voorhees Township, New Jersey, 08043, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Ohio State University College of Medicaine
Columbus, Ohio, 43210, United States
Pelvic Surgery Assoc.
Columbus, Ohio, 43222, United States
Oklahoma Univ. Medical Center
Oklahoma City, Oklahoma, 73104, United States
Corvallis Clinic
Corvallis, Oregon, 97330, United States
Kaiser Permanente Northwest Division
Portland, Oregon, 97227, United States
Womens and Infants Hospital
Providence, Rhode Island, 02905, United States
Northern Virginia Pelvic Surgery Assoc.
Annandale, Virginia, 22003, United States
Carilion Gyn/Onc
Roanoke, Virginia, 24014, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genentech, Inc.
Study Officials
- STUDY DIRECTOR
Virginia Patton, M.D.
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2004
First Posted
November 18, 2004
Study Start
January 1, 2005
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
June 10, 2015
Results First Posted
June 10, 2015
Record last verified: 2015-06