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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2008

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Xcytrin® (motexafin gadolinium)

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pharmacyclics LLC.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martin Edelman, MD, Study Chair, University of Maryland, Greenbaum Cancer Center

References

Biaglow JE, Miller RA. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. doi: 10.4161/cbt.4.1.1434. Epub 2004 Jan 8.

Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. doi: 10.1097/01.cco.0000142073.29850.98.

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