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Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

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Trial Information

Phase II Study of Gemcitabine and Cisplatin in Unresectable Malignant Mesothelioma

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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate overall survival

Outcome Time Frame:

monthly while patient on treatment. Once off treatment every 6 months

Safety Issue:


Principal Investigator

Robert N. Taub, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 1999

Completion Date:

December 2007

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • Mesothelioma



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