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

NCT00113516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2010-05-18

Study results available
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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

Interventions

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

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).

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • Canada
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00113516 on ClinicalTrials.gov