S0200 Carboplatin With or Without Doxil in Patients With Recurrent Ovarian Cancer

Phase 3

Completed

• Conditions: Ovarian Cancer; Peritoneal Cavity Cancer
• Interventions: Drug: carboplatin; Drug: pegylated liposomal doxorubicin hydrochloride

• Registration Number: NCT00043082
• Lead Sponsor: SWOG Cancer Research Network

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. It is not yet known if carboplatin is more effective with or without liposomal doxorubicin in treating recurrent ovarian epithelial or primary peritoneal cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of carboplatin with or without liposomal doxorubicin in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

* Compare overall survival of patients with platinum-sensitive recurrent ovarian epithelial or primary peritoneal cancer treated with carboplatin with or without pegylated doxorubicin HCl liposome.

* Compare progression-free survival, confirmed complete response rates, and time to treatment failure in patients treated with these regimens.

* Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease measurability (elevated CA 125 only vs nonmeasurable disease only with or without elevated CA 125 vs measurable disease), number of disease sites (2 or fewer vs 3 or more), and serous tumor histology (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl liposome IV over 1 hour on day 1.

* Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats every 4 weeks for a total of 15 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, every 6 months for 3 years, and then annually for 7 years.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study within 4 years.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2002-08-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-06
• Study Completion: 2011-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carboplatin	carboplatin	carboplatin alone
carboplatin and doxorubicin	carboplatin	carboplatin and liposomal doxorubicin given q 4 weeks
carboplatin and doxorubicin	pegylated liposomal doxorubicin hydrochloride	carboplatin and liposomal doxorubicin given q 4 weeks

Primary Outcome Measures

Name	Time	Method
overall survival	ten years	From date of registration to date of death

Secondary Outcome Measures

Name	Time	Method
progression free survival and response	10 years	response by RECIST criteria
side effects	15 months	side effects described per NCI CTC version 2.0

Trial Locations

Locations (91)

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

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

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

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

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

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

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

California Cancer Center at Woodward Park Office; 🇺🇸 Fresno, California, United States

Veterans Affairs Medical Center - Loma Linda (Pettis); 🇺🇸 Loma Linda, California, United States

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