Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

October 29, 2013 updated by: Pharmacyclics LLC.

Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

The goals of this study are:

  • to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
  • to assess response to treatment in patients with NSCLC six months after beginning study treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 2

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
    • California
      • Huntington Beach, California, United States
      • Long Beach, California, United States
    • Illinois
      • Chicago, Illinois, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
      • Santa Fe, New Mexico, United States
    • New York
      • Armonk, New York, United States
    • Ohio
      • Columbus, Ohio, United States
    • Washington
      • Seattle, Washington, United States

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Stage IIIb, metastatic, or recurrent NSCLC patients who have received one prior platinum-based chemotherapy regimen
  • ECOG performance status score of 0 or 1

Exclusion Criteria:

  • Laboratory values indicating inadequate function of bone marrow, liver, or kidneys
  • Symptomatic or uncontrolled brain metastases
  • Evidence of meningeal metastasis
  • > 1 prior regimen (not counting adjuvant or neo-adjuvant cytotoxic chemotherapy if completed > 12 months prior to regiment)
  • Medical condition that would increase risk if treated with motexafin gadolinium or impair ability to complete study procedures and assessments

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Xcytrin® (motexafin gadolinium)
Drug: Motexafin gadolinium and pemetrexed
1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles
Other Names:
  • MGd and Alimta®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 month progression free survival
Time Frame: up to 2 years
proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to disease progression
Time Frame: up to 2 years
Time to progression is defined as the time from first dose of MGd to first evidence of progression.
up to 2 years
Overall survival
Time Frame: up to 2 years
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.
up to 2 years
Progression free survival
Time Frame: up to 2 years
Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.
up to 2 years
Response rate (CR+PR) by RECIST criteria
Time Frame: up to 2 years
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.
up to 2 years
Duaration of reponse (CR+PR)
Time Frame: up to 2 years
Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.
up to 2 years
Clinical benefit rate (CR+PR+SD)
Time Frame: up to 2 years
Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment
up to 2 years
Safety and tolerability of MGd and pemetrexed
Time Frame: up to 2 years
All patients who receive any MGd will be included in the safety summaries and analyses
up to 2 years

Collaborators and Investigators

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

Sponsor

Pharmacyclics LLC.

Investigators

  • Study Chair: Martin Edelman, MD, University of Maryland, Greenbaum Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 15, 2006

First Submitted That Met QC Criteria

August 15, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Estimate)

October 31, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-0228

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.

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