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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00093132

Enrollment

Registered

2004-10-04

Start date

2004-08-31

Completion date

2009-02-28

Last updated

2012-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-small Cell Lung, Lung Cancer

Keywords

Non-Small Cell Lung Cancer (stage II or III), NSCLC, Squamous Cell Lung Cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, carcinoma, non-small cell lung

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.

Interventions

DRUGSatraplatin

Satraplatin 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Determination of MTD and recommended dose for phase II trials	30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026