Clinical trial NCT00096993: A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: Omnitarg
Cancer
Platinum-Resistant
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-18
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 1 year)
Secondary outcomes:
measure: Percentage of Participants With an Objective Response
timeFrame: Baseline to the end of the study (up to 1 year)
measure: Duration of the Objective Response
timeFrame: Baseline to the end of the study (up to 1 year)
measure: Percentage of Participants Free From Disease Progression at 4 Months
timeFrame: Baseline to Month 4
measure: Duration of Survival
timeFrame: Baseline to the end of the study (up to 1 year)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ. of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Comp. Cancer Ctr
state: California
city: Greenbrae
country: United States
facility: California Cancer Crae, Inc
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group (Kaiser)
state: California
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: Norwalk
country: United States
facility: Norwalk Medical Group
state: Connecticut
city: Stamford
country: United States
facility: Hematology Oncology, P.C.
state: Connecticut
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Savannah
country: United States
facility: Memorial Health Univ. Med. Ctr.
state: Georgia
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute
state: Idaho
city: Coeur d'Alene
country: United States
facility: North Idaho Cancer Center
state: Idaho
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic Association
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State Univ. Barbara Ann Karmanos Cancer Inst.
state: Michigan
city: Cherry Hill
country: United States
facility: Center for Cancer and Hematologic Disease
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Health System
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University College of Medicaine
state: Ohio
city: Columbus
country: United States
facility: Pelvic Surgery Assoc.
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Univ. Medical Center
state: Oklahoma
city: Corvallis
country: United States
facility: Corvallis Clinic
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest Division
state: Oregon
city: Providence
country: United States
facility: Womens and Infants Hospital
state: Rhode Island
city: Annandale
country: United States
facility: Northern Virginia Pelvic Surgery Assoc.
state: Virginia
city: Roanoke
country: United States
facility: Carilion Gyn/Onc
state: Virginia
Study officials:
affiliation: Genentech, Inc.
name: Virginia Patton, M.D.
role: STUDY_DIRECTOR
References: