Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Phase 3

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
• Interventions: Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: topotecan hydrochloride

• Registration Number: NCT00028743
• Lead Sponsor: NCIC Clinical Trials 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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.

Detailed Description

OBJECTIVES:

* Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.

* Compare the overall survival of patients treated with these regimens.

* Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens.

* Compare the toxic effects of these regimens in these patients.

* Compare the CA 125 normalization rates in patients treated with these regimens.

* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8.

* Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4.

Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion.

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

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2001-08-31
• Study First Submitted: 2002-01-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2008-03-05
• Study Completion: 2013-01-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 819

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cisplatin, Topotecan, Paclitaxel plus Carboplatin	carboplatin	Arm 1
Cisplatin, Topotecan, Paclitaxel plus Carboplatin	cisplatin	Arm 1
Cisplatin, Topotecan, Paclitaxel plus Carboplatin	topotecan hydrochloride	Arm 1
Paclitaxel plus Carboplatin	carboplatin	Arm 2
Paclitaxel plus Carboplatin	paclitaxel	Arm 2
Cisplatin, Topotecan, Paclitaxel plus Carboplatin	paclitaxel	Arm 1

Primary Outcome Measures

Name	Time	Method
Progression free survival	Mar 2008

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Dec 2012
Response Rates	March 2008
Toxic Effects	March 2008
Quality of Life	March 2008
CA125 Normalization Rates	March 2008

Trial Locations

Locations (28)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

Lions Gate Hospital; 🇨🇦 North Vancouver, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre; 🇨🇦 Surrey, British Columbia, Canada

BCCA - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

The Moncton Hospital; 🇨🇦 Moncton, New Brunswick, Canada

Atlantic Health Sciences Corporation; 🇨🇦 Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

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