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Completed

NCT Number: NCT00430261

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

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.

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Key information

Conditions

Lung Cancer Adenocarcinoma Adenocarcinoma of Lung Adenocarcinoma, Bronchiolo-Alveolar Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunitinib

Drug

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

Other names: SU011248

Primary outcomes

  1. Progression-Free Survival

    Time frame: January 2009

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2007
Registry last updated
Oct 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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