Satraplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	GPC Biotech
Information provided by:	GPC Biotech
ClinicalTrials.gov Identifier:	NCT00268970

Purpose

The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Satraplatin in combination with Paclitaxel	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel JM 216

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label
Official Title:	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)

Further study details as provided by GPC Biotech:

Primary Outcome Measures:

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

Secondary Outcome Measures:

To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel

Estimated Enrollment:	40
Study Start Date:	December 2005
Estimated Study Completion Date:	September 2007

Detailed Description:

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.

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268970

Locations

United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

GPC Biotech

More Information

Study ID Numbers:	SAT2-05-05
Study First Received:	December 22, 2005
Last Updated:	August 14, 2007
ClinicalTrials.gov Identifier:	NCT00268970
Health Authority:	United States: Food and Drug Administration

Keywords provided by GPC Biotech:

Advanced non-small cell lung cancer (NSCLC)

Study placed in the following topic categories:

Thoracic Neoplasms
Satraplatin
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009