S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery

Phase 2

Completed

• Conditions: Malignant Mesothelioma
• Interventions: Drug: gemcitabine hydrochloride

• Registration Number: NCT00003723
• 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.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients with malignant mesothelioma of the pleura that cannot be removed by surgery.

Detailed Description

OBJECTIVES: I. Estimate overall survival and confirmed and unconfirmed complete and partial response in patients with unresectable malignant mesothelioma of the pleura treated with gemcitabine plus cisplatin. II. Evaluate the qualitative and quantitative toxicities of this regimen in this patient population.

OUTLINE: Patients receive gemcitabine IV over 30 minutes, immediately followed by cisplatin IV over 30 minutes on days 1, 8, and 15. Courses are repeated every 28 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive 2 additional courses of therapy. Patients are followed every 6 months until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 25 months.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-06-23
• Study First Posted: 2004-06-24
• Primary Completion: 2007-06
• Study Completion: 2007-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine/Cisplatin	gemcitabine hydrochloride	Gemcitabine 1000 mg/m\^2 days 1, 8 15 (q 28 days) cisplatin 30 mg/m\^2 days 1, 8, 15 (q 28 days)

Primary Outcome Measures

Name	Time	Method
Estimate overall survival	monthly while patient on treatment. Once off treatment every 6 months

Secondary Outcome Measures

Name	Time	Method
qualitative and quantitative toxicities	week 1, 2, 3 (q 28 days)
confirmed and unconfirmed complete and partial response	every 8 weeks until progression

Trial Locations

Locations (84)

MBCCOP - University of South Alabama; 🇺🇸 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

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

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

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

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