A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

April 2, 2009 updated by: Pharmacyclics LLC.

Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.

A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.

Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Motexafin Gadolinium Injection

Study Type

Interventional

Enrollment

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Houston, Texas, United States, 77030
    - The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

≥ 18 years old
ECOG score of 0, 1, or 2
Histologically confirmed diagnosis of non-small cell lung cancer

Exclusion Criteria:

Laboratory values demonstrating inadequate function of the following:

Bone marrow
Kidneys
Liver

and

Peripheral neuropathy Grade 2 or higher
Greater than 2 prior chemotherapy regimens

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin

Secondary Outcome Measures

Outcome Measure
Tumor response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

January 29, 2005

First Submitted That Met QC Criteria

January 28, 2005

First Posted (Estimate)

January 31, 2005

Study Record Updates

Last Update Posted (Estimate)

April 3, 2009

Last Update Submitted That Met QC Criteria

April 2, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PCYC-0220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.