Trial Information
A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determination of MTD and recommended dose for phase II trials
Outcome Time Frame:
30 days
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
SAT1-04-02
NCT ID:
NCT00093132
Start Date:
August 2004
Completion Date:
February 2009
Related Keywords:
- Carcinoma, Non-Small Cell Lung
- Lung Cancer
- 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
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
| Southwestern Medical Center |
Dallas, Texas 75390 |
