At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 62 enrolled
Drug / intervention
temsirolimus +1 moredrug
Likely dose
Temsirolimus IV (specific dose not stated in arms or interventions)AI-extracted
Key inclusion· 5
- ✓Histologically confirmed metastatic and/or locally advanced recurrent endometrial adenocarcinoma (including papillary serous, papillary, villoglandular, mucinous, clear cell, endometrioid, or adenosquamous), incurable by standard therapies
- ✓Tumor tissue from primary tumor available for molecular marker assessment
- ✓Clinically and/or radiologically documented disease with at least one unidimensionally measurable site (≥20 mm on X-ray/physical exam, ≥10 mm on spiral CT, or ≥20 mm on non-spiral CT)
- ✓Life expectancy of at least 12 weeks
Key exclusion· 8
- ✕Prior treatment with mammalian target of rapamycin (mTOR) inhibitors
- ✕Uterine sarcomas (leiomyosarcoma), mixed mullerian tumors (MMT), and/or adenosarcomas
- ✕Non-measurable disease only (bone metastases considered non-measurable)
- ✕Known brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of CCI-779 in Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
In Brief
A Phase 2 clinical trial evaluating temsirolimus and laboratory biomarker analysis for Endometrial Adenocarcinoma and 9 related conditions. Completed, enrolled 62 participants across 1 site.
Detailed Summary
This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Adenocarcinoma, Endometrial Adenosquamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Recurrent Endometrial Carcinoma, Stage IIIA Endometrial Carcinoma, Stage IIIB Endometrial Carcinoma, Stage IIIC Endometrial Carcinoma, Stage IVA Endometrial Carcinoma, Stage IVB Endometrial Carcinoma
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2003
Enrollment StartMay 2004
Primary CompletionMay 2009
Study CompletionAug 2009
TodayJul 2026
First PostedNov 6, 2003
Enrollment StartMay 1, 2004
Primary CompletionMay 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 22.7 years ago
Interventions
temsirolimusdrug
Given IV
laboratory biomarker analysisother
Correlative studies