Patient Abstract available in the near future.

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

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and carboplatin in patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients. IV. Determine the observed responses in these patients receiving this regimen.

PROTOCOL OUTLINE: This is a dose-escalation study of gemcitabine. Patients are stratified according to prior therapy (no prior chemotherapy and/or prior radiotherapy to less than 20% of bone marrow vs prior chemotherapy and/or prior radiotherapy to at least 20% of bone marrow). Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 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 2 of 3 patients experience dose-limiting toxicity. Patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 18 patients (9 per stratum) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed advanced solid tumor for which no standard therapy exists
• No untreated brain metastases with evidence of neurologic deterioration or CNS progression

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No more than 2 prior systemic chemotherapy regimens for advanced disease; Prior adjuvant or induction therapy for initial disease allowed; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or melphalan); No prior combination carboplatin and gemcitabine
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy to more than 30% of bone marrow; At least 4 weeks since prior radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: More than 3 months
• Hematopoietic: Absolute 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
• Other: No serious concurrent infection; No other serious concurrent medical illness that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 3 months after study

Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study chairs or principal investigators

Corey Jay Langer,  Study Chair,  Fox Chase Cancer Center   

Study ID Numbers:  CDR0000068771; FCCC-97028; NCI-G01-1984
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00021346
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08