Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma
|Metastatic Gastrointestinal Carcinoid Tumor Pulmonary Carcinoid Tumor Recurrent Gastrointestinal Carcinoid Tumor Recurrent Islet Cell Carcinoma||Drug: temsirolimus Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas|
- Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria) [ Time Frame: Up to 8 years ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Stable Disease Rate Defined by RECIST Criteria [ Time Frame: Up to 8 years ]Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
- Median Survival Time [ Time Frame: 3 ]Computed using the Kaplan-Meier method.
- Survival Rate [ Time Frame: 1 year ]Computed using the Kaplan-Meier method.
- Response and Stable Disease [ Time Frame: 2 months ]Assessed using RECIST criteria.Patients that had Stable disease for 2 months
- Number of Temsirolimus Treatment Cycle Analyzed for Toxicity [ Time Frame: Duration of participants treatment upto 16wks (4cycles) of treatment ]Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3
- Time to Progression [ Time Frame: Up to 8 years ]
|Study Start Date:||December 2003|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.
Other Names:Other: laboratory biomarker analysis
I. To assess the objective tumor response rate (i.e. partial or complete responses as defined by the RECIST criteria) in patients with progressive metastatic neuroendocrine tumours given CCI-779.
II. To assess the stable disease rate and duration, time to progression, median survival time, 1-year survival rate and toxicity in patients with metastatic neuroendocrine carcinomas given CCI-779. As of 19 July 2010, overall survival follow-up is to be discontinued for the four remaining patients on long term follow-up. At that point in time, these patients had been off-treatment for 3 to 5 years. Time to progression and median survival times will be based on the currently available data.
III. To measure baseline levels of various elements up- and downstream of the mammalian target of rapamycin (mTOR). Where post-treatment biopsies are available, they will be analyzed for suppression of elements in the mTOR pathway as well as for any effect on cell cycle progression, apoptosis or anti-angiogenic effects.
OUTLINE: This is an open-label, multicenter study.
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR.
Patients are followed up for survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093782
|Princess Margaret Hospital Phase 2 Consortium|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Lillian Siu||Princess Margaret Hospital Phase 2 Consortium|