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

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

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.

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