Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer
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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 irinotecan and paclitaxel in treating patients with metastatic or recurrent cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: irinotecan hydrochloride Drug: paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Dose Escalated Irinotecan (CPT-11) With Paclitaxel in Patients With Metastatic or Recurrent Malignancies |
- Determine the maximum tolerated dose [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]Determine the maximum tolerated dose of irinotecan administered on a weekly schedule with fixed-dose weekly paclitaxel.
| Enrollment: | 21 |
| Study Start Date: | November 1996 |
| Study Completion Date: | April 2002 |
| Primary Completion Date: | February 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paclitaxel in combination with Irinotecan
The first study cohort will receive 60 mg/m2 of paclitaxel on cycle days 1, 8, and 15 as a 1 hr infusion. Immediately following paclitaxel, 30 mg/m2 irinotecan will be administered as a 90 minute intravenous infusion. Irinotecan doses will be administered in an identical infusion schedule on days 8 and 15 of each treatment cycle.
|
Drug: irinotecan hydrochloride Drug: paclitaxel |
Detailed Description:
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan administered in combination with paclitaxel in patients with metastatic or recurrent malignancies. II. Evaluate the toxicity and safety of this combination regimen in this patient population. III. Determine the pharmacokinetic profile of irinotecan in combination with paclitaxel on a weekly schedule and if the sequence of administration influences irinotecan pharmacokinetics in these patients. IV. Determine pharmacodynamic models of irinotecan and its SN-38 and SN-38G metabolites when administered in this weekly combination schedule.
OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV concurrently with paclitaxel IV weekly. Patients demonstrating stable disease or partial or complete clinical response continue with treatment as long as dose limiting toxicities are not observed and adequate performance status is maintained. Cohorts of 3 patients receive escalating doses of irinotecan until the maximum tolerated dose is determined or 150 mg/m2 is reached.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non hematologic malignancy refractory to standard therapy, or for which no known effective therapies exist
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 2,000/mm3 Absolute lymphocyte count at least 1,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminase no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No myocardial infarction within 6 months No current, uncontrolled cardiac arrhythmias Other: No history of anaphylactic reactions Not pregnant Fertile patients must use effective contraception No serious uncontrolled, concurrent medical disorder
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior paclitaxel allowed No prior irinotecan At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| Study Chair: | Hedy L. Kindler, MD | University of Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hedy Kindler, MD, Associate Professor, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00002939 History of Changes |
| Other Study ID Numbers: | 8380, UCCRC-8380, NCI-G97-1166 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Chicago:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Paclitaxel Irinotecan Camptothecin Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013