Study on Chemotherapy Combinations with or without Bevacizumab for Newly Diagnosed or Recurrent Ovarian or Fallopian Tube Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT01081262

This clinical trial is comparing different chemotherapy combinations, with or without the drug bevacizumab, to see which is more effective for treating newly diagnosed or recurrent ovarian or fallopian tube cancer.

Patient Parameters

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Program Overview

The purpose of this study is to find out which combination of chemotherapy drugs works best for treating newly diagnosed or recurrent ovarian or fallopian tube cancer. The study is comparing two main chemotherapy combinations: one with carboplatin and paclitaxel, and the other with oxaliplatin and capecitabine. Both combinations are being tested with and without an additional drug called bevacizumab, which may help block tumor growth. Researchers want to see which treatment is more effective in stopping the cancer from growing or coming back.

Description

This study is divided into several parts to evaluate the effectiveness and safety of different chemotherapy combinations for ovarian or fallopian tube cancer.

Primary Goals:

To see if the combination of oxaliplatin and capecitabine reduces the death rate compared to carboplatin and paclitaxel.
To determine if adding bevacizumab reduces the death rate compared to not using it.

Secondary Goals:

To find out if oxaliplatin and capecitabine increase the time patients live without the cancer getting worse compared to carboplatin and paclitaxel.
To see if bevacizumab increases the time patients live without the cancer getting worse.
To compare how well the cancer responds to the different drug combinations after surgery.
To assess the side effects of the different treatments.
To evaluate the impact on patients' quality of life.

Study Design:

Participants are randomly assigned to one of four treatment groups.
Group 1: Receives carboplatin and paclitaxel.
Group 2: Receives oxaliplatin and capecitabine.
Group 3: Receives carboplatin, paclitaxel, and bevacizumab.
Group 4: Receives oxaliplatin, capecitabine, and bevacizumab.
Treatments are given every 3 weeks for up to 6 cycles, with additional bevacizumab cycles for some groups.
Follow-up visits occur after treatment to monitor health and cancer status.

Eligibility Criteria

Inclusion Criteria

Diagnosed with mucinous adenocarcinoma of the ovary or fallopian tube.
Have had surgery to remove as much of the cancer as possible.
Cancer is at stage II-IV or recurrent stage I and has not been treated with chemotherapy before.
Must start treatment within 10 weeks of surgery for newly diagnosed patients or within 14 days of randomization for recurrent stage I patients.
Must have a recent negative colonoscopy.
Meet specific blood count and organ function requirements.
Agree to use effective birth control during and after treatment.
Have a life expectancy of more than 3 months.
Able to provide informed consent.

Exclusion Criteria

Have a history of colon cancer or primary peritoneal carcinoma.
Have had another invasive cancer within the last 5 years, except for certain skin cancers.
Have received prior chemotherapy or radiation for gynecologic or colorectal cancer.
Have major surgery planned during the study.
Have a history of certain heart conditions or uncontrolled high blood pressure.
Have a history of blood clots or bleeding disorders.
Are pregnant or breastfeeding.
Have active infections requiring treatment.
Are taking blood thinners like warfarin.

Locations

FACILITY	ZIP	CITY	STATE
University of Alabama at Birmingham Cancer Center	35233	Birmingham	Alabama
University of South Alabama Mitchell Cancer Institute	36688	Mobile	Alabama
Saint Joseph's Hospital and Medical Center	85013	Phoenix	Arizona
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro	72401	Jonesboro	Arkansas
Providence Saint Joseph Medical Center/Disney Family Cancer Center	91505	Burbank	California
East Bay Radiation Oncology Center	94546	Castro Valley	California
Valley Medical Oncology Consultants-Castro Valley	94546	Castro Valley	California
Bay Area Breast Surgeons Inc	94608	Emeryville	California
Epic Care Partners in Cancer Care	94608	Emeryville	California
Valley Medical Oncology Consultants-Fremont	94538	Fremont	California

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