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

Primary Purpose

Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Gemcitabine
Pertuzumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Omnitarg, Cancer, Platinum-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo + gemcitabine

Pertuzumab + gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With an Objective Response
An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
Duration of the Objective Response
Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.
Percentage of Participants Free From Disease Progression at 4 Months
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Duration of Survival
Duration of survival was defined as the time from randomization until death from any cause.

Full Information

First Posted
November 17, 2004
Last Updated
June 8, 2015
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00096993
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Keywords
Omnitarg, Cancer, Platinum-Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + gemcitabine
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Pertuzumab + gemcitabine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was provided as a single-use formulation for infusion.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine was provided as a solution for infusion.
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
rhuMAb 2C4
Intervention Description
Pertuzumab was provided as a single-use formulation for infusion.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
Baseline to the end of the study (up to 1 year)
Secondary Outcome Measure Information:
Title
Percentage of Participants With an Objective Response
Description
An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
Time Frame
Baseline to the end of the study (up to 1 year)
Title
Duration of the Objective Response
Description
Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.
Time Frame
Baseline to the end of the study (up to 1 year)
Title
Percentage of Participants Free From Disease Progression at 4 Months
Description
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame
Baseline to Month 4
Title
Duration of Survival
Description
Duration of survival was defined as the time from randomization until death from any cause.
Time Frame
Baseline to the end of the study (up to 1 year)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Patton, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Univ. of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Comprehensive Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Northwest Alabama Cancer Center
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Alta Bates Comp. Cancer Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
California Cancer Crae, Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Southern California Permanente Medical Group (Kaiser)
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Norwalk Medical Group
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Hematology Oncology, P.C.
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Memorial Health Univ. Med. Ctr.
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
North Idaho Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Wayne State Univ. Barbara Ann Karmanos Cancer Inst.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Cooper Health System
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Ohio State University College of Medicaine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pelvic Surgery Assoc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Oklahoma Univ. Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Corvallis Clinic
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Kaiser Permanente Northwest Division
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Womens and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Northern Virginia Pelvic Surgery Assoc.
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Carilion Gyn/Onc
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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