Paclitaxel in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Phase 2

Terminated

• Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00023907
• 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.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

* Determine the antitumor activity of paclitaxel in patients with recurrent or persistent platinum- and paclitaxel-resistant ovarian epithelial or primary peritoneal cancer.

* Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour once weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 6-12 months.

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-07-08
• Study First Posted: 2003-07-09
• Status Verified: 2004-05
• Primary Completion: 2006-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (44)

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

Women's Cancer Center at Community Hospital of Los Gatos; 🇺🇸 Los Gatos, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center; 🇺🇸 Orange, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

MBCCOP - Hawaii; 🇺🇸 Honolulu, Hawaii, United States

Rush-Presbyterian-St. Luke's Medical Center; 🇺🇸 Chicago, Illinois, United States

MBCCOP - University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

CCOP - Evanston; 🇺🇸 Evanston, Illinois, United States

Memorial Medical Center; 🇺🇸 Springfield, Illinois, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

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