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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to tumor progression

Principal Investigator

John P Micha, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Associates

Authority:

United States: Food and Drug Administration

Study ID:

AV53206s

NCT ID:

NCT00127920

Start Date:

August 2004

Completion Date:

August 2006

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Gynecologic Oncology AssociatesNewport Beach, California  92663
Florida Hospital College of Health SciencesOrlando, Florida  32803