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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00365183
First received: August 15, 2006
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention Phase
Non-Small Cell Lung Carcinoma
Drug: Motexafin gadolinium and pemetrexed
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • 6 month progression free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.


Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Time to progression is defined as the time from first dose of MGd to first evidence of progression.

  • Overall survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.

  • Progression free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.

  • Response rate (CR+PR) by RECIST criteria [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.

  • Duaration of reponse (CR+PR) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.

  • Clinical benefit rate (CR+PR+SD) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment

  • Safety and tolerability of MGd and pemetrexed [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    All patients who receive any MGd will be included in the safety summaries and analyses


Enrollment: 74
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MGd and Alimta®

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365183

Locations
United States, California
Huntington Beach, California, United States
Long Beach, California, United States
United States, Illinois
Chicago, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Mexico
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
United States, New York
Armonk, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Pharmacyclics
Investigators
Study Chair: Martin Edelman, MD University of Maryland, Greenbaum Cancer Center
  More Information

Publications:
Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT00365183     History of Changes
Other Study ID Numbers: PCYC-0228
Study First Received: August 15, 2006
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
Non Small Cell Lung Cancer
Lung Cancer
Metastatic Lung Cancer
Inoperable Lung Cancer
Advanced Lung Cancer
Large Cell Lung Cancer
Adenocarcinoma, lung
Squamous Cell Carcinoma, lung
Squamous Cell Lung Cancer
Large Cell Carcinoma, lung
Cancer of the Lung
Carcinoma
Bronchogenic

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Motexafin gadolinium
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists
Contrast Media
Diagnostic Uses of Chemicals
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014