Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma
|ClinicalTrials.gov Identifier: NCT00093782|
Recruitment Status : Completed
First Posted : October 8, 2004
Results First Posted : December 12, 2016
Last Update Posted : February 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Gastrointestinal Carcinoid Tumor Pulmonary Carcinoid Tumor Recurrent Gastrointestinal Carcinoid Tumor Recurrent Islet Cell Carcinoma||Drug: temsirolimus Other: laboratory biomarker analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093782
|Princess Margaret Hospital Phase 2 Consortium|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Lillian Siu||Princess Margaret Hospital Phase 2 Consortium|