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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Gynecologic Oncology Associates
ClinicalTrials.gov Identifier:
NCT00127920
First received: August 5, 2005
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: Avastin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Non-Randomized, Multi-Center Pilot Study of Intravenous Taxol, Carboplatin, Bevacizumab Given Every 21 Days in Patients With Newly Diagnosed Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Associates:

Primary Outcome Measures:
  • time to tumor progression
  • response rate

Secondary Outcome Measures:
  • safety
  • survival

Estimated Enrollment: 20
Study Start Date: August 2004
Estimated Study Completion Date: August 2006
Detailed Description:

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. 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 agents like bevacizumab (Avastin), which have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients, are being added to the optimal first line ovarian chemotherapy regimen in hopes of seeing improvement in progressive free interval and over-all survival. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab (Avastin) is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127920

Locations
United States, California
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
United States, Florida
Florida Hospital College of Health Sciences
Orlando, Florida, United States, 32803
Sponsors and Collaborators
Gynecologic Oncology Associates
Genentech, Inc.
Investigators
Principal Investigator: John P Micha, MD Gynecologic Oncology Associates
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127920     History of Changes
Other Study ID Numbers: AV53206s
Study First Received: August 5, 2005
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bevacizumab
Carboplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014