CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
temsirolimus +1 moredrug
Likely dose
Temsirolimus (CCI-779) given IVAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed neuroendocrine tumors of carcinoid histology or pancreatic islet cell origin
  • ✓Progressive metastatic disease within 6 months: ≥25% increase in disease, new lesions, or clinical deterioration
  • ✓At least one measurable lesion ≥20 mm on conventional imaging or ≥10 mm on spiral CT
  • ✓Life expectancy greater than 3 months
Key exclusion· 6
  • ✕Small cell variant, endocrine organ carcinomas, and adrenal gland malignancies (including paragangliomas)
  • ✕Known brain metastases
  • ✕Concurrent cancer from another primary site requiring treatment within past 3 years (except non-melanoma skin cancer or cervical carcinoma in situ)
  • ✕Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness limiting compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00093782
NCT00093782Phase 2Completed
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A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas

National Cancer Institute (NCI)·interventional·Posted Oct 8, 2004·Updated Feb 7, 2017

In Brief

A Phase 2 clinical trial evaluating temsirolimus and laboratory biomarker analysis for Metastatic Gastrointestinal Carcinoid Tumor and 3 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Gastrointestinal Carcinoid Tumor, Pulmonary Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 8, 2004
Enrollment StartDec 1, 2003
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 21.7 years ago

Interventions

temsirolimusdrug

Given IV

laboratory biomarker analysisother

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