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 I trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: cisplatin  Drug: gemcitabine	Phase I

Further Study Details: 

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

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

Al Bowen Benson, III,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000067303; NU-CINJ98X1; NCI-G99-1581
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004090
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08