Pilot Study of Taxol, Carboplatin, and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients

Completed · Phase 2

Conditions studied: Ovarian Neoplasms

In brief

The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like bevacizumab have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients and are being studied for their potential contributory impact on the current standard of treatment. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity. The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response rate (RR). The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy. Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy.

Key facts

Study ID

NCT00127920

Run by

Gynecologic Oncology Associates

People needed

20

Starts

2004-08-01

Expected to finish

2012-10-01

Last updated by the study team

2015-03-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
• Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
• If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
• Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.
• Karnofsky performance status > 50%.
• Subjects who have signed an institutional review board (IRB) approved informed consent form.

You may not qualify if…

• Subjects with epithelial ovarian cancer of low malignancy potential.
• Subjects with septicemia, severe infection, or acute hepatitis.
• Subjects with severe gastrointestinal bleeding.
• Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.

Where it is running

• Gynecologic Oncology Associates — Newport Beach, California, United States
• Florida Hospital College of Health Sciences — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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