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Phase 2 Trial of First-Line Therapy With Satraplatin and Paclitaxel in Patients With Unresectable Stage III or IV Non-small Cell Lung Cancer (NSCLC)


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

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Trial Information

Phase 2 Trial of First-Line Therapy With Satraplatin and Paclitaxel in Patients With Unresectable Stage III or IV Non-small Cell Lung Cancer (NSCLC)


This trial is designed to study the efficacy and safety of a novel oral platinum analog,
satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line
of treatment (patients who have not received chemotherapy for disease that has metastasized)
of patients with advanced NSCLC.

WHAT IS 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.


Inclusion Criteria:



- Histologically confirmed advanced NSCLC

- Patients must not have received any prior antineoplastic chemotherapy or
investigational product for lung cancer prior to study entry.

- Patients must have at least one unidimensionally measurable lesion definable by
magnetic resonance imaging (MRI) or computed tomography (CT) scan.

- ECOG performance status of ≤ 2.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel

Outcome Time Frame:

3 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

SAT2-05-05

NCT ID:

NCT00268970

Start Date:

December 2005

Completion Date:

September 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Advanced non-small cell lung cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Sarah Cannon Research InstituteNashville, Tennessee  37203