Spots Global Cancer Trial Database for Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer

Official Title: Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer

Study ID: NCT00129844

Conditions

Adenocarcinoma

Non-Small-Cell Lung Carcinoma

Lung Neoplasms

Interventions

Motexafin Gadolinium

Study Description

Brief Summary: The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.

Detailed Description: Outline: Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms: Arm A - 10 mg/kg MGd once per week Arm B - 15 mg/kg MGd once every 3 weeks Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study. At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.