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

This study has been terminated.
(Sponsor decided to discontinue study drug development.)
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00093132
First received: October 1, 2004
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-small Cell Lung
Lung Cancer
Drug: Satraplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Agennix:

Primary Outcome Measures:
  • Determination of MTD and recommended dose for phase II trials [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: August 2004
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Satraplatin
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093132

Locations
United States, Texas
Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Agennix
  More Information

No publications provided

Responsible Party: Agennix
ClinicalTrials.gov Identifier: NCT00093132     History of Changes
Other Study ID Numbers: SAT1-04-02
Study First Received: October 1, 2004
Last Updated: August 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Satraplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014