Satraplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00268970|
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : April 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Satraplatin in combination with Paclitaxel||Phase 2|
This trial is designed to study the efficacy and safety of a novel oral platinum analog, satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line of treatment (patients who have not received chemotherapy for disease that has metastasized) of patients with advanced NSCLC.
WHAT IS SATRAPLATIN:
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of First-Line Therapy With Satraplatin and Paclitaxel in Patients With Unresectable Stage III or IV Non-small Cell Lung Cancer (NSCLC)|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||September 2009|
- Drug: Satraplatin in combination with Paclitaxel
Paclitaxel 200 mg/m2 IV over 3 hours on day 1. Satraplatin 60 mg/m2 administered by mouth once daily for 5 consecutive days (days 1-5). Satraplatin will be administered within 2 hours following paclitaxel infusion on day 1. Subsequent doses on days 2-5 will be taken at approximately 24 hour intervals.
- To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel [ Time Frame: 3 months ]
- To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel [ Time Frame: 3 months ]
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): NCT00268970
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|