Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer

This study has been completed.

First Received: February 15, 2005 Last Updated: August 8, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00103831

Purpose

A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and efficacy of this combination will be studied.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Oral Taxane	Phase I Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study
Official Title:	Phase I Alimta Combination With BMS-275183 (Oral Taxane)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced or metastatic pretreated NSCLC
Measurable disease
Adequate hematologic, hepatic and renal functions.
ECOG Performance Status 0-2

Exclusion Criteria:

Inability to swallow capsules
Recent significant cardiovascular disease
Women who are pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103831

Locations

United States, Colorado
Local Institution
Denver, Colorado, United States
United States, Minnesota
Local Institution
Rochester, Minnesota, United States
Canada, Ontario
Local Institution
Toronto, Ontario, Canada

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CA165-021
Study First Received:	February 15, 2005
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00103831 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

NSCLC - non-small cell lung cancer

Study placed in the following topic categories:

Pemetrexed
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Taxane
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Taxane
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009