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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-small Cell Lung, Lung Cancer

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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 CenterDallas, Texas  75390