S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission

Phase 3

Completed

• Conditions: Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer
• Interventions: Drug: paclitaxel

• Registration Number: NCT00003120
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known whether giving paclitaxel for a shorter period of time is as effective as a standard course of treatment for advanced ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel given for 3 months with that of paclitaxel given for 12 months in treating patients who have stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Detailed Description

OBJECTIVES: I. Compare the effect of continuing paclitaxel for 12 months versus 3 months on progression free survival and overall survival in women with advanced ovarian, fallopian tube, or peritoneal cancer who attained complete remission on initial platinum (carboplatin or cisplatin) and paclitaxel based chemotherapy. II. Assess the toxic effects associated with prolonged paclitaxel administration in these patients.

OUTLINE: This is a randomized study. Patients are stratified by stage (optimal stage III vs suboptimal stage III vs stage IV), prior treatments with paclitaxel (over at least 24 hours vs over less than 24 hours), and age (65 and under vs over 65). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression or 1 year from registration, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 5 years.

Study Timeline

• Study Start: 1997-11
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-06
• Study First Submitted QC: 2004-02-19
• Study First Posted: 2004-02-20
• Study Completion: 2012-11
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 308

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paclitaxel 3 cycles	paclitaxel	paclitaxel given for 3 cycles
paclitaxel for 12 cycles	paclitaxel	paclitaxel given for 12 cycles

Primary Outcome Measures

Name	Time	Method
progression-free survival	duration between date of enrollment and date first recurrence or death due to any cause.

Trial Locations

Locations (93)

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

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

Veterans Affairs Medical Center - Phoenix (Hayden); 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan); 🇺🇸 Little Rock, Arkansas, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

Scripps Clinic Cancer Center; 🇺🇸 La Jolla, California, United States

Veterans Affairs Medical Center - Long Beach; 🇺🇸 Long Beach, California, United States

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