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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

carboplatin

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

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

sunitinib

Intervention Type DRUG

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 sunitinib in a separate continuation protocol).

Interventions

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carboplatin

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

Intervention Type DRUG

paclitaxel

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

Intervention Type DRUG

sunitinib

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 sunitinib in a separate continuation protocol).

Intervention Type DRUG

Other Intervention Names

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Paraplatin Taxol SUTENT, SU011248

Eligibility Criteria

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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
* Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Newark, Delaware, United States

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Pfizer Investigational Site

Newark, Delaware, United States

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Pfizer Investigational Site

Wilmington, Delaware, United States

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Pfizer Investigational Site

Maywood, Illinois, United States

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Pfizer Investigational Site

Jeffersonville, Indiana, United States

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Pfizer Investigational Site

Louisville, Kentucky, United States

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Pfizer Investigational Site

Louisville, Kentucky, United States

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Pfizer Investigational Site

Louisville, Kentucky, United States

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Pfizer Investigational Site

Shelbyville, Kentucky, United States

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Pfizer Investigational Site

Hershey, Pennsylvania, United States

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Pfizer Investigational Site

Franklin, Tennessee, United States

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Pfizer Investigational Site

Gallatin, Tennessee, United States

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Pfizer Investigational Site

Hermitage, Tennessee, United States

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Pfizer Investigational Site

Lebanon, Tennessee, United States

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