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

Stopped early · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-small Cell Lung, Lung Cancer

In brief

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.

Key facts

Study ID

NCT00093132

Run by

Agennix

People needed

20

Starts

2004-08-01

Expected to finish

2009-02-01

Last updated by the study team

2012-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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