Brief Title
S9810: Gemcitabine Plus Cisplatin in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot Be Removed by Surgery
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 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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Estimate overall survival
Secondary Outcome
qualitative and quantitative toxicities
Condition
Malignant Mesothelioma
Intervention
gemcitabine hydrochloride
Study Arms / Comparison Groups
Gemcitabine/Cisplatin
Description: Gemcitabine 1000 mg/m^2 days 1, 8 15 (q 28 days) cisplatin 30 mg/m^2 days 1, 8, 15 (q 28 days)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
57
Start Date
February 1999
Completion Date
December 2007
Primary Completion Date
June 2007
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of unresectable malignant
mesothelioma of the pleura Epithelial, fibrosarcomatous, or mixed type Bidimensionally
measurable disease No CNS metastases
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least lower limit of
normal Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.5 times
upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN AND Creatinine
clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use
effective contraception No other prior malignancy within the past 5 years except adequately
treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or
adequately treated stage I or II cancer currently in complete remission Must have chest
x-ray within the past 28 days
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent hormones for
non-disease-related conditions allowed Concurrent steroids for antiemesis, adrenal failure,
or septic shock allowed Radiotherapy: No prior radiotherapy No concurrent radiotherapy
Surgery: At least 4 weeks since prior major surgery and recovered
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert N. Taub, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00003723
Organization ID
CDR0000066832
Secondary IDs
SWOG-S9810
Responsible Party
Sponsor
Study Sponsor
Southwest Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Robert N. Taub, MD, PhD, Study Chair, Herbert Irving Comprehensive Cancer Center
Verification Date
October 2012