A Study of Axitinib in Advanced Carcinoid Tumors (NCT01435122) | Clinical Trial Compass
CompletedPhase 2
A Study of Axitinib in Advanced Carcinoid Tumors
United States30 participantsStarted 2011-10-25
Plain-language summary
The main purpose of this study is to see whether Axitinib will help prolong the time that the patient's carcinoid tumors remain stable, and to examine their treatment response through testing. Researchers also want to find out if Axitinib is safe and tolerable.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Locally unresectable or metastatic well-and moderately-differentiated (low- or intermediate- grade) neuroendocrine tumors of the aerodigestive tract (e.g. foregut, midgut, and hindgut) and unknown primary site as well as rare primary sites (renal, ovarian, thymic, hepatic); Otherwise known as typical or atypical carcinoid tumors
* Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
* Functional or nonfunctional tumors allowed
* Evidence of progressive disease within 12 months of study entry
* Adequate hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN)mg/dl; aspartic transaminase (AST) ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases)
* Adequate renal function: serum creatinine ≤ 1.5 x ULN
* Adequate bone marrow function: absolute neutrophil count ≥ 1,500/mm³; platelets ≥75,000/mm³
* Prothrombin time (PT) and activated partial thromboplastin time (aPTT) levels ≤1.5 x ULN (unless patients receiving coumadin anticoagulation in which case a stable international normalization ration (INR) of 2-3 is required).
* Urine protein \<2+proteinuria (or \<2 g proteinuria /24 hr)
* Prior somatostatin-analog therapy required in patients with midgut carcinoid tumors
* Minimum 4 weeks since completion of prior treatment (investigational or other). Prior treatment with chemotherapy, radiotherapy, hepatic artery embolization, surgery or other therapeutic agents is allowed.
* Treatment related toxicity should have r…
What they're measuring
1
Rate of Progression Free Survival (PFS)
Timeframe: 12 Months
2
Median Progression Free Survival
Timeframe: Up to 36 Months
Trial details
NCT IDNCT01435122
SponsorH. Lee Moffitt Cancer Center and Research Institute