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

Primary Purpose

Carcinoma, Non-small Cell Lung, Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Satraplatin

About this trial

This is an interventional treatment trial for Carcinoma, Non-small Cell Lung focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Satraplatin

Arm Description

Satraplatin

Outcomes

Primary Outcome Measures

Determination of MTD and recommended dose for phase II trials

Secondary Outcome Measures

Full Information

NCT ID

NCT00093132

First Posted

October 1, 2004

Last Updated

August 9, 2012

Sponsor

Agennix

1. Study Identification

Unique Protocol Identification Number

NCT00093132

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decided to discontinue study drug development.

Study Start Date

August 2004 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Agennix

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Satraplatin

Arm Type

Experimental

Arm Description

Satraplatin

Intervention Type

Drug

Intervention Name(s)

Satraplatin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Determination of MTD and recommended dose for phase II trials

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

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

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