A Phase I Trial of Dose Escalated Irinotecan (CPT-11) With Paclitaxel in Patients With Metastatic or Recurrent Malignancies
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Trial of Dose Escalated Irinotecan (CPT-11) With Paclitaxel in Patients With Metastatic or Recurrent Malignancies
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximum tolerated dose
Outcome Description:
Determine the maximum tolerated dose of irinotecan administered on a weekly schedule with fixed-dose weekly paclitaxel.
Outcome Time Frame:
3 weeks
Safety Issue:
Yes
Principal Investigator
Hedy L. Kindler, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Chicago
Authority:
United States: Federal Government
Study ID:
8380
NCT ID:
NCT00002939
Start Date:
November 1996
Completion Date:
April 2002
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
