Status: Closed
Activation Date: 2011JUL14
Closing Date: 2015FEB05
Phase: II
Description: A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.
Eligibility: Patients with recurrent, unresectable, locally advanced or metastatic rare tumours: vascular sarcomas (non-pediatric); clear cell carcinomas of ovary, endometrium; medullary thyroid carcinoma; non-pancreatic neuroendocrine tumours: pheochromocytoma, paragangliomas; adrenocortical carcinoma; thymic carcinoma; fibrolamellar hepatocellular carcinoma; rare tumours with somatic mutations in VEGFR, PDGFR, KIT, RET; rare tumours arising from known/suspected germline mutations in PTEN, TS, LKB1, NF1/2. Unidimensionally measurable disease. Archival tissue or fresh biopsy required at study entry. No limit on prior chemotherapy or radiation therapy, although no prior treatment with mTOR inhibitor (for temsirolimus) or VEGFR, PDGFR, RET or KIT inhibitor (for sunitinib) permitted. No uncontrolled hypertension, therapeutic doses of coumadin-derivative anticoagulants, or certain CYP3A4 inhibitors/inducers permitted on sunitinib arm.
Objective: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 weeks every 6 weeks and temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent rare tumours. To assess the adverse events, time to progression and response duration of sunitinib orally and temsirolimus given IV weekly in patients with rare tumours. To assess time to first and second progression for patients who receive sunitinib and temsirolimus in sequence. To explore the relationship between genetic alterations in the genome in archival and/or fresh tumour tissue and blood samples from patients on this trial and their objective response to therapy. To assess the consistency of diagnosis of rare tumours through central review of pathology specimens.
Participation: Limited to invited centres
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I206 | 137 | 87 | 134 | 135 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I206 | 137 | 1 | 15 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I206 | 137 | 1 | 0 | 120 | 0 | 0 | 0 | 0 | 0 |