Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00389974 |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with unresectable, locally advanced or metastatic cervical cancer.
Condition | Intervention | Phase |
---|---|---|
Cervical Cancer |
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), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients With Unresectable, Locally Advanced or Metastatic Cervical Carcinoma |
Estimated Enrollment: | 32 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, nonrandomized study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients with responding disease receive 2 courses beyond complete response or stable partial response.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed carcinoma of the cervix, including any of the following subtypes:
Meets 1 of the following criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Measurable disease must be present outside previously irradiated area
PATIENT CHARACTERISTICS:
No history of NYHA class II cardiac function unless both of the following criteria are met:
None of the following within the past year:
No serious illness or medical condition that would preclude study treatment including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Prior radiotherapy allowed, including external beam and/or intracavity radiotherapy
No prior anthracycline exposure or central thoracic radiotherapy that included the heart in the radiation port unless both of the following criteria are met:
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 concurrent therapeutic coumadin-derivative anticoagulants (e.g., warfarin) except for doses ≤ 2 mg per day for prophylaxis of thrombosis
No concurrent agents with proarrhythmic potential, including any of the following:
Canada, British Columbia | |
BCCA - Fraser Valley Cancer Centre | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
British Columbia Cancer Agency - Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Canada, Ontario | |
Edmond Odette Cancer Centre at Sunnybrook | |
Toronto, Ontario, Canada, M4N 3M5 | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
McGill Cancer Centre at McGill University | |
Montreal, Quebec, Canada, H3G 1Y6 | |
Canada, Saskatchewan | |
Allan Blair Cancer Centre at Pasqua Hospital | |
Regina, Saskatchewan, Canada, S4T 7T1 |
Study Chair: | Helen J. Mackay, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000509467, CAN-NCIC-IND184 |
Study First Received: | October 18, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00389974 |
Health Authority: | United States: Food and Drug Administration |
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma recurrent cervical cancer |
stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer |
Epidermoid carcinoma Sunitinib Squamous cell carcinoma Carcinoma, squamous cell Adenocarcinoma |
Carcinoma, Squamous Cell Carcinoma, Adenosquamous Recurrence Carcinoma |
Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |