Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase 2

Completed

• Conditions: Fallopian Tube Cancer; Peritoneal Cancer; Ovarian Cancer
• Interventions: Drug: Bevacizumab; Drug: Gemcitabine; Drug: Carboplatin

• Registration Number: NCT00267696
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-19
• Study First Posted: 2005-12-21
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Results First Submitted: 2015-02-09
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-28
• Last Update Submitted: 2015-04-28
• Results First Posted: 2015-04-30
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine/carboplatin/bevacizumab	Bevacizumab	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.
Gemcitabine/carboplatin/bevacizumab	Gemcitabine	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.
Gemcitabine/carboplatin/bevacizumab	Carboplatin	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.

Primary Outcome Measures

Name	Time	Method
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.	up to 6 months	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

Name	Time	Method
Overall Survival for Patients Treated With the Regimen.	To progression of Disease	The period of time from study entry until disease progression or date of last contact.

Trial Locations

Locations (1)

The Ohio State University & James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States