Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Carcinoma, Large Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Micronutrients

Hematinics

Vitamins

Pemetrexed

Motexafin gadolinium

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Photosensitizing Agents

Folinic Acid

Folate

Vitamin B9

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

Motexafin gadolinium and pemetrexed

Martin Edelman, MD

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.

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

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

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

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

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

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

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

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

All patients who receive any MGd will be included in the safety summaries and analyses

Pharmacyclics LLC.

Docetaxel

Cisplatin

Motexafin Gadolinium Injection

The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.

A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.

Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer	NCT00365183	Non-Small Cell ...	Motexafin gadol...	18 Years -	Pharmacyclics LLC.
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer	NCT00365183	Non-Small Cell ...	Motexafin gadol...	18 Years -	Pharmacyclics LLC.
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)	NCT00102505	Non-Small-Cell ... Carcinoma, Bron...	Motexafin Gadol...	18 Years -	Pharmacyclics LLC.

Spots Global Cancer Trial Database for squamous cell carcinoma, lung