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

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agennix
• Treatments: Satraplatin

Criteria

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