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Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00638937 |
RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well AZD0530 works in treating patients with recurrent, stage IIIB or stage IV non-small cell lung cancer previously treated with combination chemotherapy that included cisplatin or carboplatin.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: AZD0530 Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of AZD0530 in Patients With Advanced, Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Combination Chemotherapy |
Estimated Enrollment: | 32 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Tumor tissue samples are collected at baseline and at 2 weeks after beginning treatment and are analyzed for c-Src protein expression and activity by immunofluorescence staining. P-glycoprotein levels and phosphorylation of focal adhesion kinase (FAK), paxillin, caveolin, and Stat-3 are also measured using tumor tissue samples. Blood samples are also used to measure levels of VEGF by ELISA.
After completion of study treatment, patients are followed every 8 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer, meeting both of the following criteria:
Previously treated with first-line platinum-based systemic chemotherapy for advanced disease AND had at least stabilization of disease as best response to first-line therapy
PATIENT CHARACTERISTICS:
No cardiac dysfunction including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
No CYP3A4-active agents or substances for 7 days prior to, during, and for 7 days after completion of study treatment, including any of the following:
Canada, Ontario | |
Margaret and Charles Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Peter Ellis, MD 905-387-9495 ext. 64602 | |
Ottawa Hospital Regional Cancer Centre - General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Scott A. Laurie, MD, FRCPC 613-737-7700 ext. 70173 | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Natasha Leighl, MD, FRCPC 416-946-4645 | |
Canada, Quebec | |
Royal Victoria Hospital - Montreal | Recruiting |
Montreal, Quebec, Canada, H3A 1A1 | |
Contact: Vera Hirsh, MD, FRCPC 514-934-1934 ext. 36952 vera.hirsh@muhc.mcgill.ca |
Study Chair: | Scott A. Laurie, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
Study ID Numbers: | CDR0000587610, PMH-PHLO-053 |
Study First Received: | March 18, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00638937 |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Carboplatin Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |