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

August 9, 2012 updated by: Agennix

A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Satraplatin
Drug: Satraplatin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of MTD and recommended dose for phase II trials
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agennix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

October 1, 2004

First Submitted That Met QC Criteria

October 1, 2004

First Posted (ESTIMATE)

October 4, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 9, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAT1-04-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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