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

Last updated on December 4, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90048 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00113516
Pfizer
Completed
A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

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Descriptive Information
Brief Title  ICMJE A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Brief SummaryThe 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).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: carboplatin
    AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.
    Other Name: Paraplatin
  • Drug: paclitaxel
    175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.
    Other Name: Taxol
  • 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).
    Other Name: SUTENT, SU011248
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: carboplatin
  • Drug: paclitaxel
  • Drug: sunitinib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2009)
84
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion DateMarch 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00113516
Other Study ID Numbers  ICMJE A6181057
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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