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

Pharmacyclics

Status and phase: Terminated; Phase 2

Conditions: Non-Small Cell Lung Carcinoma

Treatments: Drug: Motexafin gadolinium and pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00365183

PCYC-0228

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Xcytrin® (motexafin gadolinium)

Experimental group

Treatment:

Drug: Motexafin gadolinium and pemetrexed