Combination Chemotherapy in Treating Patients With Previously Untreated Stage III or Stage IV Ovarian or Primary Peritoneal Cancer

Phase 1

Terminated

• Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00003378
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients with previously untreated stage III or stage IV ovarian or primary peritoneal cancer.

Detailed Description

OBJECTIVES: I. Determine the feasibility of administering multiple courses of chemotherapy without excessive dose modification or treatment delay in patients with previously untreated ovarian epithelial carcinoma or primary peritoneal carcinoma. II. Determine the response rate (in patients with measurable disease) and progression-free interval in these patients receiving this treatment.

OUTLINE: This is a feasibility study. On day 1, patients receive paclitaxel as a 3 hour continuous IV infusion followed by carboplatin as a 30 minute infusion. Gemcitabine is administered by continuous infusion over 30 minutes on day 1 following carboplatin and on day 8. In the absence of disease progression or unacceptable toxicity, courses repeat every 21 days for a maximum of 8 courses. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within approximately 2 years.

Study Timeline

• Study Start: 1998-08
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-02
• Study First Submitted QC: 2004-08-25
• Study First Posted: 2004-08-26
• Status Verified: 2011-12
• Last Update Submitted: 2013-07-08
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (64)

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

CCOP - Greater Phoenix; 🇺🇸 Phoenix, Arizona, United States

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA; 🇺🇸 Los Angeles, California, United States

Women's Cancer Center; 🇺🇸 Palo Alto, California, United States

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States

Vincent T. Lombardi Cancer Research Center, Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Emory University Hospital - Atlanta; 🇺🇸 Atlanta, Georgia, United States

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