Study Evaluating MAC-321 in Non-Small Cell Lung Cancer Refractory to Platinum-Based Therapy - Full Text View

Purpose

This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen.

A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung Lung Neoplasms	Drug: MAC-321	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label

Official Title:	A Phase 2, Open-Label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-Small Cell Lung Cancer Refractory to Platinum-Based Therapy

Eligibility

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

Criteria

Inclusion Criteria:

Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent
Recovery from all acute side effects of prior therapies (with the exception of hair loss)
Adequate bone marrow, liver, and kidney function

Exclusion Criteria:

More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens)
Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study
Symptomatic brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063219

Locations


United States, California

	Los Angeles, California, United States, 90033

United States, Kentucky

	Lexington, Kentucky, United States, 40536-0098

United States, Maryland

	Baltimore, Maryland, United States, 21231-1000

United States, Massachusetts

	Worcester, Massachusetts, United States, 01655

United States, Minnesota

	Minneapolis, Minnesota, United States, 55455

United States, Missouri

	St. Louis, Missouri, United States, 63110

United States, New York

	New York, New York, United States, 10032

United States, North Carolina

	Charlotte, North Carolina, United States, 28203

United States, Ohio

	Cleveland, Ohio, United States, 44195

United States, Pennsylvania

	Philadelphia, Pennsylvania, United States, 19140

	Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

	Charleston, South Carolina, United States, 29425

United States, Tennessee

	Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Study ID Numbers:	3128K1-201
First Received:	June 23, 2003
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00063219
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Non-Small-Cell Lung Carcinoma

Lung Cancer

Cancer of Lung

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00063219