CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Temsirolimus + Weekly Paclitaxel + Carboplatindrug
Likely dose
Temsirolimus + Weekly Paclitaxel + Carboplatin 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01016769
NCT01016769Phase 2Completed
CompareCT.gov

A Phase I/II Study of Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

Memorial Sloan Kettering Cancer Center·interventional·Posted Nov 19, 2009·Updated Jun 26, 2019

In Brief

A Phase 2 clinical trial evaluating Temsirolimus + Weekly Paclitaxel + Carboplatin for Squamous Cell Cancer and Head and Neck Cancer. Completed, enrolled 48 participants across 5 sites.

Detailed Summary

The purpose of this study is to find out the good and bad effects that occur when temsirolimus is added to standard chemotherapy with carboplatin and paclitaxel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Cancer, Head and Neck Cancer
CountriesUnited States
CollaboratorsNATL COMP CA NETWORK, Pfizer

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2009
Enrollment StartNov 1, 2009
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 16.6 years ago

Interventions

Temsirolimus + Weekly Paclitaxel + Carboplatindrug

Temsirolimus Per dose escalation scheme Level 1 (15 mg) 2 (20 mg) Level 3 (25 mg) IVPB 30 minutes weekly (3 weeks on, 1 week off) days 1 and 8. Paclitaxel 80 mg/m2 IVPB 1 hour weekly (2 weeks on, 1 week off) days 1 and 8. Carboplatin AUC 1.5 IVPB 30 minutes days 1 and 8. On Day 15 of each cycle, patients begin the rest week.