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

NCT ID: NCT00093132

Last Updated: 2012-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-02-28

Brief Summary

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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

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Conditions

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Carcinoma, Non-small Cell Lung Lung Cancer

Keywords

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Satraplatin

Satraplatin

Group Type EXPERIMENTAL

Satraplatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agennix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SAT1-04-02

Identifier Type: -

Identifier Source: org_study_id