Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy
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|ClinicalTrials.gov Identifier: NCT00093132|
Recruitment Status : Terminated (Sponsor decided to discontinue study drug development.)
First Posted : October 4, 2004
Last Update Posted : August 17, 2012
PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
RATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-small Cell Lung Lung Cancer||Drug: Satraplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||February 2009|
Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
- Determination of MTD and recommended dose for phase II trials [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093132
|United States, Texas|
|Southwestern Medical Center|
|Dallas, Texas, United States, 75390|