Orlando, Florida 32803

  • Ovarian Neoplasms

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

AV53206s


NCT ID:

NCT00127920


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Gynecologic Oncology Associates


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:John P Micha, MD
Principal Investigator
Gynecologic Oncology Associates

Study Dates

Start Date:August 2004
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:March 2015
Last Changed Date:March 9, 2015
First Received Date:August 5, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:survival
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:safety
Safety Issues:False
Outcome Type:Primary Outcome
Measure:response rate
Safety Issues:False
Outcome Type:Primary Outcome
Measure:time to tumor progression
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Avastin
Description:Paclitaxel, Carboplatin and Avastin given on day 1 every 21 days
Arm Name:Single Arm
Other Name:Bevacizumab

Study Arms

Study Arm Type:Experimental
Arm Name:Single Arm
Description:Paclitaxel, Carboplatin and Avastin on day1 every 21 days

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gynecologic Oncology Associates
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Genentech, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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