Back to resultsStudy of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Primary Purpose
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Gemcitabine
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, platinum sensitive cancer, fallopian tube cancer, peritoneal cancer
Eligibility Criteria
Inclusion Criteria: Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment. Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present. History of at least one therapy of platinum based chemotherapy. Exclusion Criteria: Participation in another experimental drug study Heart disease or high blood pressure History of a stroke within the past 6 months Vascular disease, or bleeding problems Brain cancer Major Surgical Procedure within 28 days prior to start date Minor surgical procedures within 7 days prior to start date Pregnant or lactating Abdominal or bowel problems like bleeding History of abdominal fistula, GI perforation or Intra-abdominal abscess Serious, non-healing wound, ulcer or bone fracture Acute hepatitis Active infections requiring antibiotics Inability to comply with study or follow up procedures
Sites / Locations
- The Ohio State University & James Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine/carboplatin/bevacizumab
Arm Description
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Outcomes
Primary Outcome Measures
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
Secondary Outcome Measures
Overall Survival for Patients Treated With the Regimen.
The period of time from study entry until disease progression or date of last contact.
Full Information
NCT ID
NCT00267696
First Posted
December 19, 2005
Last Updated
April 28, 2015
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Genentech, Inc., Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00267696
Brief Title
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Official Title
A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Genentech, Inc., Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
Detailed Description
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Keywords
ovarian cancer, platinum sensitive cancer, fallopian tube cancer, peritoneal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine/carboplatin/bevacizumab
Arm Type
Experimental
Arm Description
A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin®
Intervention Description
Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Primary Outcome Measure Information:
Title
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
Description
Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Overall Survival for Patients Treated With the Regimen.
Description
The period of time from study entry until disease progression or date of last contact.
Time Frame
To progression of Disease
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
History of at least one therapy of platinum based chemotherapy.
Exclusion Criteria:
Participation in another experimental drug study
Heart disease or high blood pressure
History of a stroke within the past 6 months
Vascular disease, or bleeding problems
Brain cancer
Major Surgical Procedure within 28 days prior to start date
Minor surgical procedures within 7 days prior to start date
Pregnant or lactating
Abdominal or bowel problems like bleeding
History of abdominal fistula, GI perforation or Intra-abdominal abscess
Serious, non-healing wound, ulcer or bone fracture
Acute hepatitis
Active infections requiring antibiotics
Inability to comply with study or follow up procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry J. Copeland, MD
Organizational Affiliation
Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University & James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18829088
Citation
Richardson DL, Backes FJ, Seamon LG, Zanagnolo V, O'Malley DM, Cohn DE, Fowler JM, Copeland LJ. Combination gemcitabine, platinum, and bevacizumab for the treatment of recurrent ovarian cancer. Gynecol Oncol. 2008 Dec;111(3):461-6. doi: 10.1016/j.ygyno.2008.08.011. Epub 2008 Sep 30. Erratum In: Gynecol Oncol. 2010 Dec;119(3):603. Dosage error in article text.
Results Reference
result
Links:
URL
http://cancer.osu.edu
Description
Jamesline
Learn more about this trial
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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