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Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Gemcitabine (10 mg/m2/Min) and Cisplatin: A Phase I Study

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of gemcitabine and
cisplatin in patients with metastatic or recurrent nonhematologic malignancies.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine IV on
days 1 and 8, followed immediately by cisplatin IV over 2 hours on day 8. Courses repeat
every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 5 patients experience dose limiting toxicity. Patients are followed every 3
months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 18 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent
nonhematologic malignancy that is not amenable to or has failed standard therapy
Measurable or evaluable disease No uncontrolled brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At
least 8 weeks Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times
upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at
least 60 mL/min Pulmonary: No respiratory failure Other: Not pregnant or nursing Fertile
patients must use effective contraception No active infection or other concurrent severe
medical illness that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks since nitrosoureas) and recovered No prior cisplatin or
gemcitabine Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Al B. Benson, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

August 2002

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Cancer Institute of New Jersey New Brunswick, New Jersey  08901