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 combination chemotherapy in treating patients who have advanced solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: cisplatin  Drug: docetaxel  Drug: fluorouracil  Drug: leucovorin calcium	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel administered in combination with cisplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors. II. Determine the toxicities associated with this combination regimen in this patient population. III. Evaluate the clinical response to this combination regimen in these patients.

PROTOCOL OUTLINE: This is a dose escalation study of docetaxel and fluorouracil (5-FU). Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 2, and leucovorin calcium IV immediately followed by 5-FU IV on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression. Cohorts of 3-5 patients receive escalating doses of docetaxel and 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics--

• Diagnosis of advanced solid tumor
• No lymphomas
• Measurable disease

--Prior/Concurrent Therapy--

• No more than 2 prior treatments for metastatic disease
• Biologic therapy: Not specified
• Chemotherapy: No prior high dose (pre transplant) chemotherapy Prior paclitaxel allowed
• Endocrine therapy: Not specified
• Radiotherapy: No prior pelvic radiotherapy
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: Neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than upper limit of normal (ULN) AND SGOT no greater than 2.5 times ULN AND Alkaline phosphatase no greater than ULN OR SGOT no greater than ULN AND Alkaline phosphatase no greater than 5 times ULN
• Renal: Creatinine no greater than 2.0 mg/dL
• Other: No pre-existing peripheral neuropathy greater than grade 2; Not pregnant or nursing; Fertile patients must use effective contraception

Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000067593; NU-98X2; NCI-G00-1707
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004913
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08