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 irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer.

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

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies. II. Evaluate the toxicity and safety of this combination regimen in this patient population. III. Determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics in these patients. IV. Determine pharmacodynamic models of irinotecan and its SN-38 and SN-38G metabolites when administered in this weekly combination schedule.

PROTOCOL OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV concurrently with paclitaxel IV weekly. Patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained. Cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mg/m2 is reached.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed non hematologic malignancy refractory to standard therapy, or for which no known effective therapies exist

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Prior paclitaxel allowed; No prior irinotecan; At least 4 weeks since prior chemotherapy
• Endocrine therapy: No concurrent steroids
• Radiotherapy: At least 4 weeks since prior radiotherapy

Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100%
• Life expectancy: At least 3 months
• Hematopoietic: Platelet count at least 100,000/mm3; Absolute neutrophil count at least 2,000/mm3; Absolute lymphocyte count at least 1,000/mm3
• Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminase no greater than 2.5 times upper limit of normal
• Renal: Creatinine no greater than 1.4 mg/dL
• Cardiovascular: No myocardial infarction within 6 months; No current, uncontrolled cardiac arrhythmias
• Other: No history of anaphylactic reactions; Not pregnant; Fertile patients must use effective contraception; No serious uncontrolled, concurrent medical disorder

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States

Study chairs or principal investigators

Hedy L. Kindler,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000065386; UCCRC-8380; NCI-G97-1166
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002939
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08