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

Phase 1

Terminated

• Conditions: Carcinoma, Non-small Cell Lung; Lung Cancer
• Interventions: Drug: Satraplatin

• Registration Number: NCT00093132
• Lead Sponsor: Agennix

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2004-10-01
• Study First Submitted QC: 2004-10-01
• Study First Posted: 2004-10-04
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Status Verified: 2012-08
• Disposition First Submitted: 2012-08-09
• Disposition First Submitted QC: 2012-08-09
• Last Update Submitted: 2012-08-09
• Disposition First Posted: 2012-08-17
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Satraplatin	Satraplatin	Satraplatin

Primary Outcome Measures

Name	Time	Method
Determination of MTD and recommended dose for phase II trials	30 days

Trial Locations

Locations (1)

Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States