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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma

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 Summary:

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.


Sponsor: Southwest Oncology Group

Current Primary Outcome: Estimate overall survival [ Time Frame: monthly while patient on treatment. Once off treatment every 6 months ]

Original Primary Outcome:

Current Secondary Outcome:

  • qualitative and quantitative toxicities [ Time Frame: week 1, 2, 3 (q 28 days) ]
  • confirmed and unconfirmed complete and partial response [ Time Frame: every 8 weeks until progression ]


Original Secondary Outcome:

Information By: Southwest Oncology Group

Dates:
Date Received: November 1, 1999
Date Started: February 1999
Date Completion:
Last Updated: October 5, 2012
Last Verified: October 2012