Clinical Trial: Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 6, 2004
Date Started: December 2003
Date Completion:
Last Updated: December 14, 2016
Last Verified: December 2016