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Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Jonathan Wright, MD

Investigator Role:

Study Chair

Investigator Affiliation:

State University of New York - Upstate Medical University

Authority:

United States: Federal Government

Study ID:

SUNY-HSC-3732

NCT ID:

NCT00003555

Start Date:

July 1998

Completion Date:

May 2003

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

State University of New York - Upstate Medical UniversitySyracuse, New York  13210