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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 May 11, 2018

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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[email protected]

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A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
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).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • 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
Experimental: 1
Interventions:
  • Drug: carboplatin
  • Drug: paclitaxel
  • Drug: sunitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
March 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   United States
 
 
NCT00113516
A6181057
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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