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

NCT ID: NCT01210053

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

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

Group Type EXPERIMENTAL

malate Given orally

Intervention Type DRUG

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

Interventions

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malate Given orally

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

Intervention Type DRUG

Other Intervention Names

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sutent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Third Military Medical University

Principal Investigators

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yang zhenzhou, doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yang zhenzhou, doctor

Role: CONTACT

Facility Contacts

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yang zhenzhou, doctor

Role: primary

Other Identifiers

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Yang-001

Identifier Type: -

Identifier Source: org_study_id