Phase II Trial of Sunitinib in BAC or Never-Smokers With Any Lung Adenocarcinoma
This study has been completed.
Sponsor:
Swedish Medical Center
Collaborator:
Pfizer
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00430261
First received: January 30, 2007
Last updated: October 5, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Adenocarcinoma |
Drug: sunitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Sunitinib in Bronchoalveolar Carcinoma or Never-Smokers With Any Lung Adenocarcinoma |
Resource links provided by NLM:
Further study details as provided by Swedish Medical Center:
Primary Outcome Measures:
- Progression-Free Survival [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: sunitinib
50mg po qd x 4 weeks on followed by 2 weeks off for a 6 week cycle.
Other Name: SU011248
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430261
Locations
| United States, Washington | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
Swedish Medical Center
Pfizer
Investigators
| Principal Investigator: | Howard West, M.D. | Swedish Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Howard jack West, M.D., Swedish Medical Center, Swedish Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00430261 History of Changes |
| Other Study ID Numbers: | CRC 05160 |
| Study First Received: | January 30, 2007 |
| Last Updated: | October 5, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Swedish Medical Center:
|
bronchoalveolar carcinoma BAC adenocarcinoma lung cancer |
oral Stage IIIB and IV lung cancer Any bronchoalveolar carcinoma (BAC) Any adenocarcinoma in a never-smoker |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases 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 May 23, 2013