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

NCT00113516 | Completed Phase 2 Results

• 1 other identifier: A6181057
• Study Type: interventional
• Target: 84
• Locations: 3 countries
• Sites: 31

Brief Summary

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).

Conditions

Non-small Cell Lung Cancer

Keywords

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Surviving at One Year

  Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.

  From start of treatment until 1 year or death

Secondary Outcomes (36)

• Progression-free Survival (PFS)

  From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death

• Time to Tumor Progression (TTP)

  From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)

• Duration of Response (DR)

  From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death

• Number of Subjects With Overall Confirmed Objective Disease Response

  From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)

• Overall Survival (OS)

  From start of study treatment until death

Study Arms (1)

1

EXPERIMENTAL

Drug: carboplatin; Drug: paclitaxel; Drug: sunitinib

Interventions

carboplatin DRUG

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

Also known as: Paraplatin

1

paclitaxel DRUG

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

Also known as: Taxol

1

sunitinib 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).

Also known as: SUTENT, SU011248

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (31)

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19713, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19718, United States

Location

Pfizer Investigational Site

Wilmington, Delaware, 19899, United States

Location

Pfizer Investigational Site

Maywood, Illinois, 60153, United States

Location

Pfizer Investigational Site

Jeffersonville, Indiana, 47130, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40241, United States

Location

Pfizer Investigational Site

Shelbyville, Kentucky, 40065, United States

Location

Pfizer Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Pfizer Investigational Site

Franklin, Tennessee, 37067, United States

Location

Pfizer Investigational Site

Gallatin, Tennessee, 37066, United States

Location

Pfizer Investigational Site

Hermitage, Tennessee, 37076, United States

Location

Pfizer Investigational Site

Lebanon, Tennessee, 37087, United States

Location

Pfizer Investigational Site

Murfreesboro, Tennessee, 37130, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203-1632, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37205, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37207, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37211, United States

Location

Pfizer Investigational Site

Smyrna, Tennessee, 37167, United States

Location

Pfizer Investigational Site

Burleson, Texas, 76028, United States

Location

Pfizer Investigational Site

Cleburne, Texas, 76031, United States

Location

Pfizer Investigational Site

Fort Worth, Texas, 76104, United States

Location

Pfizer Investigational Site

Mineral Wells, Texas, 76067, United States

Location

Pfizer Investigational Site

Weatherford, Texas, 76086, United States

Location

Pfizer Investigational Site

Vancouver, British Columbia, V5Z4E6, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2L 4M1, Canada

Location

Pfizer Investigational Site

Caen, 14076, France

Location

Pfizer Investigational Site

Villejuif, 94805, France

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Carboplatin; Paclitaxel; Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 8, 2005
• First Posted: June 9, 2005
• Study Start: September 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 18, 2010
• Results First Posted: May 10, 2010

Record last verified: 2010-05

Locations

US (27); CA (2); FR (2)