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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00392444 |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura.
Condition | Intervention | Phase |
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Malignant Mesothelioma |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase II Study of Sunitinib (SU11248; NSC 736511; IND 74019) in Patients With Advanced Malignant Pleural Mesothelioma |
Estimated Enrollment: | 57 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, nonrandomized, open-label study. Patients are stratified according to prior cytotoxic chemotherapy (yes vs no).
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant pleural mesothelioma
Measurable disease, defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional teachniques or ≥ 10 mm by spiral CT scan
Meets 1 of the following criteria for prior cytotoxic chemotherapy treatment:
PATIENT CHARACTERISTICS:
Patients with the following histories allowed provided they are asymptomatic with respect to cardiac function and LVEF is normal by MUGA at baseline:
No cardiac disease within the past 12 months, including any of the following:
No bowel obstruction or any condition that would impair the ability to swallow and retain sunitinib malate, including any of the following:
No serious illness or medical condition that would preclude study treatment including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No prior treatment with any other antiangiogenic agents or multitargeted tyrosine kinase inhibitors, including any of the following:
No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
No concurrent agents with proarrhythmic potential, including any of the following:
Canada | |
L'Hopital Laval | Recruiting |
Quebec, Canada, G1V 4G5 | |
Contact: Francis Laberge 418-656-4747 | |
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Quincy Chu 780-432-8248 | |
Canada, British Columbia | |
BCCA - Fraser Valley Cancer Centre | Recruiting |
Surrey, British Columbia, Canada, V3V 1Z2 | |
Contact: Christopher Lee 604-930-4017 | |
British Columbia Cancer Agency - Centre for the Southern Interior | Recruiting |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
Contact: Delia Sauciuc 250-712-3900 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Nevin Murray 604-877-6000 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | Recruiting |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Contact: Wojciech Morzycki 902-473-8317 | |
Canada, Ontario | |
Margaret and Charles Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: John Goffin 905-387-9495 | |
Ottawa Hospital Regional Cancer Centre - General Campus | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Scott Laurie 613-737-7700 | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Ronald Feld 416-946-2260 |
Study Chair: | Scott A. Laurie, MD, FRCPC | Ottawa Hospital Regional Cancer Centre - General Campus |
Study ID Numbers: | CDR0000509318, CAN-NCIC-IND183 |
Study First Received: | October 25, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00392444 |
Health Authority: | Unspecified |
advanced malignant mesothelioma recurrent malignant mesothelioma |
Sunitinib Mesothelioma Adenoma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Mesothelial Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |