Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002939

Enrollment

Registered

2004-04-29

Start date

1996-11-30

Completion date

2002-04-30

Last updated

2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

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.

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.

Interventions

DRUGirinotecan hydrochloride

DRUGpaclitaxel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Determine the maximum tolerated dose	3 weeks	Determine the maximum tolerated dose of irinotecan administered on a weekly schedule with fixed-dose weekly paclitaxel.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026