Clinical trial NCT00365183: Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Official title: Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Carcinoma
Keywords: 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
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2006-08-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 6 month progression free survival
timeFrame: up to 2 years
Secondary outcomes:
measure: Time to disease progression
timeFrame: up to 2 years
measure: Overall survival
timeFrame: up to 2 years
measure: Progression free survival
timeFrame: up to 2 years
measure: Response rate (CR+PR) by RECIST criteria
timeFrame: up to 2 years
measure: Duaration of reponse (CR+PR)
timeFrame: up to 2 years
measure: Clinical benefit rate (CR+PR+SD)
timeFrame: up to 2 years
measure: Safety and tolerability of MGd and pemetrexed
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Huntington Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Santa Fe
country: United States
state: New Mexico
city: Armonk
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: University of Maryland, Greenbaum Cancer Center
name: Martin Edelman, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.