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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00096993
First received: November 17, 2004
Last updated: December 22, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Drug: rhuMAb 2C4 (pertuzumab)
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • To assess the efficacy and to evaluate the safety and tolerability of pertuzumab in combination with gemcitabine relative to gemcitabine in combination with placebo in subjects with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer

Enrollment: 131
Study Start Date: November 2004
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096993

  Hide Study Locations
Locations
United States, Alabama
Univ. of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Alta Bates Comp. Cancer Ctr
Berkeley, California, United States, 94704
California Cancer Crae, Inc
Greenbrae, California, United States, 94904
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, Los Angeles
Los Angeles, California, United States, 90095
Ventura County Hematology Oncology Specialists
Oxnard, California, United States, 93030
Sutter Cancer Center
Sacramento, California, United States, 95816
Sharp Healthcare
San Diego, California, United States, 92123
Southern California Permanente Medical Group (Kaiser)
San Diego, California, United States, 92120
United States, Connecticut
Norwalk Medical Group
Norwalk, Connecticut, United States, 06856
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902
United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
Florida Hospital
Orlando, Florida, United States, 32804
United States, Georgia
Memorial Health Univ. Med. Ctr.
Savannah, Georgia, United States, 31404
United States, Idaho
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Carle Clinic Association
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
St. Vincent Hospital
Indianapolis, Indiana, United States, 46260
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Wayne State Univ. Barbara Ann Karmanos Cancer Inst.
Detroit, Michigan, United States, 48201
United States, New Jersey
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
Cooper Health System
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
Pelvic Surgery Assoc.
Columbus, Ohio, United States, 43222
Ohio State University College of Medicaine
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Univ. Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Corvallis Clinic
Corvallis, Oregon, United States, 97330
Kaiser Permanente Northwest Division
Portland, Oregon, United States, 97227
United States, Rhode Island
Womens and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Virginia
Northern Virginia Pelvic Surgery Assoc.
Annandale, Virginia, United States, 22003
Carilion Gyn/Onc
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Genentech
Investigators
Study Director: Virginia Patton, M.D. Genentech
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00096993     History of Changes
Other Study ID Numbers: TOC3258g
Study First Received: November 17, 2004
Last Updated: December 22, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Omnitarg
Cancer
Platinum-Resistant

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 15, 2014