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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Carcinoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 month progression free survival

Outcome Description:

proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.

Outcome Time Frame:

up to 2 years

Safety Issue:

No

Principal Investigator

Martin Edelman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland, Greenbaum Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

PCYC-0228

NCT ID:

NCT00365183

Start Date:

June 2006

Completion Date:

June 2008

Related Keywords:

  • Non-Small Cell Lung Carcinoma
  • 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
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Fountain Valley, California  92708
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Seattle, Washington  98195
Albuquerque, New Mexico  87131-5636
Baltimore, Maryland  21287