Paclitaxel Plus Chemoprotection With Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors

NCT ID: NCT00003555

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-07-31
• Study Completion Date: 2003-05-31

Brief Summary

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.

Detailed Description

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

amifostine trihydrate

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory solid tumors Evaluable disease

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Principal Investigators

Jonathan Wright, MD

Role: STUDY_CHAIR

State University of New York - Upstate Medical University

Locations

State University of New York - Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

CDR0000066614

Identifier Type: REGISTRY

Identifier Source: secondary_id

ALZA-98-012-ii

Identifier Type: -

Identifier Source: secondary_id

NCI-V98-1463

Identifier Type: -

Identifier Source: secondary_id

SUNY-HSC-3732

Identifier Type: -

Identifier Source: org_study_id