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

Condition(s) targeted: Non-Small Cell Lung Carcinoma

Intervention: Motexafin gadolinium and pemetrexed (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Pharmacyclics

Official(s) and/or principal investigator(s):
Martin Edelman, MD, Study Chair, Affiliation: University of Maryland, Greenbaum Cancer Center

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.

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

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 6 month progression free survival

Secondary outcome:

To estimate: Time to progression

Overall survival

Progression free survival

Overall response rate

Duration of response

Clinical benefit rate

Safety and tolerability of the combination of motexafin gadolinium and pemetrexed

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Huntington Beach, California, United States

Long Beach, California, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Minneapolis, Minnesota, United States

St. Louis, Missouri, United States

Albuquerque, New Mexico, United States

Santa Fe, New Mexico, United States

Armonk, New York, United States

Columbus, Ohio, United States

Seattle, Washington, United States

Related publications:

Biaglow JE. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. 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. Review.

Starting date: June 2006
Last updated: March 13, 2008