Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Carcinoma
- Interventions
- Registration Number
- NCT00365183
- Lead Sponsor
- Pharmacyclics LLC.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Xcytrin® (motexafin gadolinium) Motexafin gadolinium and pemetrexed -
- Primary Outcome Measures
Name Time Method 6 month progression free survival up to 2 years proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.
- Secondary Outcome Measures
Name Time Method Duaration of reponse (CR+PR) up to 2 years Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.
Time to disease progression up to 2 years Time to progression is defined as the time from first dose of MGd to first evidence of progression.
Overall survival up to 2 years Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.
Safety and tolerability of MGd and pemetrexed up to 2 years All patients who receive any MGd will be included in the safety summaries and analyses
Progression free survival up to 2 years Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.
Response rate (CR+PR) by RECIST criteria up to 2 years Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.
Clinical benefit rate (CR+PR+SD) up to 2 years Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment