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

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Carboplatin; Drug: Bevacizumab; Drug: Gemcitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00267696

OSU-05070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Gemcitabine/carboplatin/bevacizumab

Experimental group

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.

Treatment:

Drug: Carboplatin

Drug: Gemcitabine

Drug: Bevacizumab