Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Third Military Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01210053
First received: September 27, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether sunitinib is effective in treating non-small cell lung cancer.

PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as maintenance therapy in treating patients with stage III or stage IV non-small cell lung cancer which is previously treated with combination chemotherapy.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: malate Given orally
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: This Phase II Trial is Studying Sunitinib to See How Well it Works When Given as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Which is Previously Treated With Combination Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Drug: malate Given orally
Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
Other Name: sutent

Detailed Description:

OBJECTIVES:

Primary

  • To investigate the effect of sunitinib malate on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer Secondary
  • To evaluate the toxicity of sunitinib when administered in the maintenance setting.
  • To evaluate the additional response rate to sunitinib malate when administered in the maintenance setting.
  • To evaluate the overall survival of patients treated with sunitinib. After completion of study treatment, patients are followed every 2 months for 1 year, every 6 months for 1 year, and periodically for 3 years.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
  • Histologically or cytologically confirmed primary non-small cell lung cancer who have stable or responding disease after prior treatment with 3-6 courses of platinum -based therapy
  • Not a candidate for combined modality therapy
  • No cavitary lesions

Exclusion Criteria:

  • Evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210053

Contacts
Contact: yang zhenzhou, doctor yangzhenzhou@sohu.com

Locations
China, Chongqing
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: yang zhenzhou, doctor       yangzhenzhou@sohu.com   
Sponsors and Collaborators
Third Military Medical University
Investigators
Principal Investigator: yang zhenzhou, doctor Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  More Information

No publications provided

Responsible Party: yangzhenzhou, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01210053     History of Changes
Other Study ID Numbers: Yang-001
Study First Received: September 27, 2010
Last Updated: September 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Third Military Medical University:
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014