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

Tracking Information

First Received Date ^ICMJE

September 27, 2010

Last Updated Date

September 27, 2010

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

• 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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: malate Given orally

Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.

Other Name: sutent

Study Arm (s)

Experimental: Single arm

Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.

Intervention: Drug: malate Given orally

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2012

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: yang zhenzhou, doctor

yangzhenzhou@sohu.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01210053

Other Study ID Numbers ^ICMJE

Yang-001

Has Data Monitoring Committee

Yes

Responsible Party

yangzhenzhou, Third Military Medical University

Study Sponsor ^ICMJE

Third Military Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

yang zhenzhou, doctor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Information Provided By

Third Military Medical University

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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