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A Phase I Trial of Dose Escalated Irinotecan (CPT-11) With Paclitaxel in Patients With Metastatic or Recurrent Malignancies


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

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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 CenterChicago, Illinois  60637