Satraplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC)...
Brief Summary
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)”
The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Detailed Clinical Trial Description
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.
Intervention(s) in this Clinical Trial
- Drug: Satraplatin in combination with Paclitaxel
Outcome Measures for this Clinical Trial
Primary Measures
- To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Histologically confirmed advanced NSCLC
- Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry.
- Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
- ECOG performance status of ≤ 2.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: GPC Biotech Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00268970
Study ID Number: SAT2-05-05
ClinicalTrials.gov Identifier: NCT00268970
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00268970
