This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Given IV
Correlative studies
Princess Margaret Hospital Phase 2 Consortium
Toronto, Ontario, Canada
Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)
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.
Time frame: Up to 8 years
Stable Disease Rate Defined by RECIST Criteria
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.
Time frame: Up to 8 years
Median Survival Time
Computed using the Kaplan-Meier method.
Time frame: 3
Survival Rate
Computed using the Kaplan-Meier method.
Time frame: 1 year
Response and Stable Disease
Assessed using RECIST criteria.Patients that had Stable disease for 2 months
Time frame: 2 months
Number of Temsirolimus Treatment Cycle Analyzed for Toxicity
Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3
Time frame: Duration of participants treatment upto 16wks (4cycles) of treatment
Time to Progression
Time frame: Up to 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.