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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002587 |
Purpose
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 paclitaxel plus topotecan in treating patients who have solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: paclitaxel Drug: topotecan hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL (TAXOL) |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 1994 |
OBJECTIVES: I. Determine the maximum tolerated dose and quantitative and qualitative toxic effects of topotecan and paclitaxel in patients with solid tumors. II. Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of topotecan and paclitaxel. Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan IV continuously on days 1-14. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study within 8-12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven solid tumor Measurable or evaluable disease Measurable disease defined as tumor outside prior radiotherapy fields and reproducibly measurable in 2 dimensions on physical exam, x-ray, CT, or MRI
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0 or 1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No poorly controlled angina No history of congestive heart failure No myocardial infarction within the past 6 months Other: Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic hematopoietic growth factors Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Other: No concurrent medications altering cardiac conduction
Contacts and Locations| United States, New York | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Howard S. Hochster, MD | New York University School of Medicine |
More Information
| Study ID Numbers: | CDR0000063738, NYU-9315, NCI-T93-0115D |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002587 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Paclitaxel Therapeutic Uses Mitosis Modulators Tubulin Modulators |
Enzyme Inhibitors Antimitotic Agents Topotecan Antineoplastic Agents, Phytogenic Pharmacologic Actions |
