A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00113516

Purpose

The purpose of this study is to find out if SU011248 provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if SU011248 is safe for patients with metastatic Non Small Cell Lung Cancer (NSCLC).

Condition	Intervention	Phase
Lung Neoplasms	Drug: carboplatin Drug: paclitaxel Drug: SU011248	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Paclitaxel Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

One year survival [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
Objective response rate [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
Safety [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	September 2005
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: carboplatin AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices. Drug: paclitaxel 175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices. Drug: SU011248 50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive SU011248 in a separate continuation protocol).

Arms

Assigned Interventions

1: Experimental

Drug: carboplatin

AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.

Drug: paclitaxel

175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.

Drug: SU011248

50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive SU011248 in a separate continuation protocol).

Eligibility

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

Criteria

Inclusion Criteria:

Histologically proven NSCLC
Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
No prior therapy for NSCLC
Evidence of unidimensionally measurable disease

Exclusion Criteria:

Previous treatment with systemic chemotherapy for lung cancer
History of or known brain metastases
NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
Evidence of hemoptysis within 4 weeks of starting study treatment
Serious acute or chronic illness or recent history of significant cardiac abnormality

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113516

Show 32 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181057
Study First Received:	June 8, 2005
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00113516
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

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

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009