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Sponsored by: |
State University of New York - Upstate Medical University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003555 |
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 | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: amifostine trihydrate Drug: paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Supportive Care |
Official Title: | Use of Weekly One Hour Paclitaxel Infusion With Dose Escalation for Recurrent and Resistant Cancers, Using Amifostine as a Cytoprotector |
Estimated Enrollment: | 20 |
Study Start Date: | July 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, New York | |
State University of New York - Upstate Medical University | |
Syracuse, New York, United States, 13210 |
Study Chair: | Jonathan Wright, MD | State University of New York - Upstate Medical University |
Study ID Numbers: | CDR0000066614, SUNY-HSC-3732, ALZA-98-012-ii, NCI-V98-1463 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003555 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Radiation-Protective Agents Amifostine Paclitaxel Tubulin Modulators |
Antimitotic Agents Antineoplastic Agents, Phytogenic Recurrence |
Radiation-Protective Agents Amifostine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents |
Protective Agents Pharmacologic Actions Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |