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

Agennix

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Drug: Satraplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093132

SAT1-04-02

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Satraplatin

Experimental group

Description:

Satraplatin

Treatment:

Drug: Satraplatin