Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Docetaxel

Motexafin gadolinium

Photosensitizing Agents

On Day 1 of each 3 week cycle for up to 12 cycles:

MGd 10 mg/kg infused over approximately 30 to 60 minutes, followed ≥ 30 minutes later by Docetaxel 75 mg/m2 administered IV over approximately 1 hour.

Motexafin Gadolinium

Kishan Pandya, MD

The purpose of this study is to determine if the addition of motexafin gadolinium (study drug) to standard treatment with docetaxel will improve the response rate in patients with non-small cell lung cancer.

Preclinical and clinical data suggest that MGd has activity in NSCLC and that the combination of MGd and docetaxel may be more effective that docetaxel alone. In this trial, patients will receive 10 mg/kg MGd followed by 75 mg/m2 once every 3 weeks. This dosing regimen was well tolerated in the Phase I dose escalation trial. A Simon 2-stage trial design will be used; if at least 4 out of 39 evaluable patients in the first stage of the trial demonstrate objective clinical response, the study will proceed to Stage 2, where an additional 22 evaluable patients will be enrolled following the same treatment regimen and assessment schedule as in Stage 1. Patients with stable disease, CR, or PR will continue dosing up to 12 cycles and will be followed for response every 6 weeks until PD, death, or end of study.

Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)

Phase II Trial of Motexafin Gadolinium and Docetaxel for Second Line Treatment of Patients With Advanced Non-small Cell Lung Cancer

The patient population for the primary endpoint is all patients who underwent at least 1 cycle of treatment and at 1 response evaluation.

The progression is defined as the time fromfirst does of MGd to first eviedence of progression

The patient population for this endpoint is all patients who received at least 1 dose of MGd and docetaxel

Progression-free survival is defined as the time from first does of MGd to the earlier of progression

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

The patient population for this endpoint is all patients who underwent at least 2 cycles of treatment and at least 1 response evaluation

All patients who receive at one dose of MGd will be included in the safety summaries and analyses

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)	NCT00373204	Lung Cancer	Motexafin Gadol...	18 Years -	Pharmacyclics LLC.
Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)	NCT00373204	Lung Cancer	Motexafin Gadol...	18 Years -	Pharmacyclics LLC.
Study of the Effect on Non-small Cell Lung Cancer of the Investigational Drug Motexafin Gadolinium When Used in Combination With Docetaxel (Taxotere)	NCT00373204	Lung Cancer	Motexafin Gadol...	18 Years -	Pharmacyclics LLC.

Spots Global Cancer Trial Database for second line treatment for advanced lung cancer