Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer

Conditions
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Carcinoma, Non-small Cell Lung, Lung Cancer

Intervention / Treatment
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* Drug: Satraplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced or medically inoperable NSCLC (stage II or III) ECOG performance status score 0-2 Adequate bone marrow, liver, and pulmonary functions Life expectancy > three months. Exclusion Criteria: Prior malignancy Serious concurrent uncontrolled medical disorder. Uncontrolled or significant cardiovascular disease History of mastectomy Pregnant or breast-feeding patients are not eligible Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Satraplatin<br>Satraplatin | Drug: Satraplatin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of MTD and recommended dose for phase II trials |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenosquamous cell lung cancer, NSCLC, Non-Small Cell Lung Cancer (stage II or III), Squamous Cell Lung Cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, carcinoma, non-small cell lung