Multicenter Phase II Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer

Sanofi1 site in 1 country35 target enrollmentJune 2000

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsDocetaxel Irinotecan

DrugsDocetaxel Irinotecan

Overview

Phase: Phase 2
Intervention: Docetaxel
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Sanofi
Enrollment: 35
Locations: 1
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of the study is to determine the activity of the weekly combination of docetaxel (Taxotere) and irinotecan in terms of response rate in subjects with advanced, previously untreated, non-small cell lung cancer. It is also to determine the activity of this combination in terms of response duration, time to progression, median survival, overall survival, and percent one-year survival, as well as the side-effect and toxicity profile of weekly Taxotere and weekly irinotecan.

Registry

clinicaltrials.gov

Start Date

June 2000

End Date

January 2003

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Microscopically or cytologically confirmed non-small cell lung cancer. Histology may include large cell, squamous cell, undifferentiated, or bronchioalveolar carcinoma, or adenocarcinoma, but no small cell or carcinoid.
•Inoperable stage III B or metastatic stage IV NSCLC
•Measurable (bidimensionally) indicator lesion(s) which have not been irradiated.
•No prior systemic chemotherapy. Prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal or there must be radiologic proof of progressive disease. If a patient is receiving palliative radiation, other than the chest, to one site at 30 cGy or less, then the patient is eligible and chemotherapy can proceed immediately after palliative RT.
•ECOG performance status 0 or 1 at screening and on the first day of treatment
•Life expectancy = 12 weeks.
•Patients must be \> 4 weeks from prior radiation therapy to the pelvis, spine or long bones, and must be recovered from all side effects.
•Patients must be \> 3 weeks from prior major surgery, except for a simple biopsy or placement of a venous access device.

Exclusion Criteria

•No patient may have the following:
•Neutrophils \< 1,500/mm
•Platelets \< 100,000/mm
•Serum creatinine \>1.8 mg/dL.
•SGOT \> 1.5 times the upper limit of normal for institution.
•Total bilirubin \> the upper limit of normal for institution.
•Alkaline phosphatase \> 5 times the upper limit of normal for institution.
•Pregnant or lactating females or females of childbearing potential not employing adequate contraception.
•History of other malignancy within the last five years which could affect the diagnosis of NSCLC, except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
•Current metastatic CNS disease, if present, must have been treated and clinically stable for at least 3 weeks prior to initial Taxotere treatment. Patients with documented meningeal carcinomatosis are not eligible.