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

Phase 2TerminatedNCT00365183

Pharmacyclics LLC.74 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Carcinoma

Interventions

Motexafin gadolinium and pemetrexedDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Huntington Beach, California, United States

Unnamed facility

Long Beach, California, United States

Unnamed facility

Chicago, Illinois, United States

Unnamed facility

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

6 month progression free survival

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

Time frame: up to 2 years

Secondary Outcomes

Time to disease progression

Time to progression is defined as the time from first dose of MGd to first evidence of progression.

Time frame: up to 2 years

Overall survival

Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.

Time frame: up to 2 years

Progression free survival

Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.

Time frame: up to 2 years

Response rate (CR+PR) by RECIST criteria

Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.

Time frame: up to 2 years

Duaration of reponse (CR+PR)

Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.

Time frame: up to 2 years

Clinical benefit rate (CR+PR+SD)

Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment

Time frame: up to 2 years

Data from ClinicalTrials.gov

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