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Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma

NCT ID: NCT00430261

Last Updated: 2010-10-06

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-10-31

Brief Summary

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This is an open-label study of a new oral drug for advanced stage (IIIB or IV) lung cancer. The cancer must be EITHER bronchoalveolar carcinoma (BAC) type, or if the patient is a never-smoker (less than 100 cigarettes lifetime) the cancer can be any type of adenocarcinoma.

Detailed Description

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To participate in this study, patients must have disease that can be measured on a CT scan. Brain metastases are OK if stable. Pregnant and/or nursing women may not participate. This drug has been approved by the FDA for the treatment of advanced renal cell cancer and a certain type of stomach/intestinal cancer. Its efficacy in lung cancer in currently unknown. Common side effects include fatigue, nausea, diarrhea, skin reaction, and decreased blood counts.

Conditions

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Lung Cancer Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sunitinib

50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.

Intervention Type DRUG

Other Intervention Names

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SU011248

Eligibility Criteria

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Inclusion Criteria

* Bronchoalveolar carcinoma with disease measurable on CAT scan
* Any lung adenocarcinoma in a never-smoker (less than 100 cigarettes lifetime) with disease measurable on CAT scan
* Stage IIIB or IV

Exclusion Criteria

* Uncontrolled hypertension
* Unstable brain metastases
* Pregnant/nursing women
* Uncontrolled thyroid disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Swedish Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Swedish Medical Center, Swedish Cancer Institute

Principal Investigators

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Howard West, M.D.

Role: PRINCIPAL_INVESTIGATOR

Swedish Cancer Institute

Locations

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Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CRC 05160

Identifier Type: -

Identifier Source: org_study_id