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/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: docetaxel  Drug: irinotecan	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when combined with docetaxel in patients with advanced solid malignancies. II. Determine the dose limiting toxicity of this regimen in these patients. III. Assess any antitumor activity of this regimen in these patients.

PROTOCOL OUTLINE: This is a dose escalation, multicenter study of irinotecan. Patients receive docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven solid malignancy for which no effective therapy is currently available
• CNS metastases allowed if CNS disease is stable for at least 4 weeks following completion of surgery and/or radiotherapy

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy regimens containing topotecan, irinotecan, or docetaxel; At least 4 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas, melphalan, or mitomycin)
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior wide field radiotherapy; No prior radiotherapy to greater than 20% of bone marrow
• Surgery: See Disease Characteristics; Recovered from any prior surgery
• Other: No other concurrent investigational agents

--Patient Characteristics--

• Age: Over 18
• Performance status: At least 3 months
• Life expectancy: ECOG 0-2
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin less than 1.2 mg/dL; SGOT and/or SGPT no greater than 1.5 times upper limit of normal (ULN) (no greater than 2.5 times ULN allowed if alkaline phosphatase no greater than ULN); Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4 times ULN allowed if SGOT and/or SGPT no greater than ULN)
• Renal: Creatinine clearance at least 55 mL/min
• Other: HIV negative; No active infection; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No concurrent medical condition that would preclude compliance with study

Connecticut
      Bennett Cancer Center, Stamford,  Connecticut,  06902,  United States
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States

Study chairs or principal investigators

John R. Murren,  Study Chair,  Yale Cancer Center   

Study ID Numbers:  CDR0000067606; YALE-HIC-10023; NCI-G00-1700
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004923
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08