RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of paclitaxel plus chemoprotection with amifostine in treating patients with recurrent or refractory solid tumors.

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

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of weekly paclitaxel following amifostine in patients with recurrent or refractory solid tumors.

II. Assess tumor response rate and survival in these patients.

PROTOCOL OUTLINE: This is a dose escalation study of paclitaxel.

Patients receive amifostine IV over 5 minutes or less on day 0, followed by paclitaxel IV over 1 hour once a week for 6 weeks followed by 2 weeks of rest. Patients with complete or partial response may receive additional courses of therapy.

Cohorts of 3-5 patients each receive increasing doses of paclitaxel. The maximum tolerated dose is defined as the dose level prior to the cohort at which 1 of 3-5 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven recurrent or refractory solid tumors
• Evaluable disease

--Prior/Concurrent Therapy--

• Biologic therapy: Prior biologic therapy allowed
• Chemotherapy: No more than 3 prior failed chemotherapy regimens; Prior paclitaxel as a radiosensitizer allowed; No prior weekly paclitaxel infusion failure; Prior platinum or paclitaxel therapy allowed
• Endocrine therapy: Prior endocrine therapy allowed
• Radiotherapy: Prior radiotherapy allowed
• Surgery: Prior surgery allowed
• Other: No concurrent dilantin therapy; No antihypertensive/diuretics within 24 hours prior to chemotherapy

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Greater than 4 months
• Hematopoietic: Neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 8 g/dL
• Hepatic: Bilirubin less than 1.5 g/dL; Alkaline phosphatase less than 3 times upper limit of normal (ULN); AST less than 3 times ULN
• Renal: Calcium greater than 8 mg/dL; Creatinine clearance greater than 60 mL/min
• Cardiovascular: No active congestive heart failure
• Other: Not pregnant or nursing; Fertile patients must use effective contraception; No grade 2 neuropathy; No intolerability for hydration

New York
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States

Study chairs or principal investigators

Jonathan Wright,  Study Chair,  State University of New York   

Study ID Numbers:  CDR0000066614; SUNY-HSC-3732; NCI-V98-1463; ALZA-98-012-ii
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003555
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08