CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Pemetrexed +1 moredrug
Likely dose
Pemetrexed 500 mg/m² IV day 1 every 21 days followed by bevacizumab 15 mg/kg IV every 21 daysAI-extracted
Key inclusion· 6
  • ✓Metastatic or locally recurrent squamous cell carcinoma of the head and neck judged incurable by locoregional therapy
  • ✓Cytologically or histologically confirmed squamous cell carcinoma (excluding WHO II/III nasopharyngeal carcinoma)
  • ✓Unidimensional measurable disease per RECIST; if only site is in previously irradiated area, must have documented disease progression
  • ✓ECOG performance status 0-1
Key exclusion· 11
  • ✕Prior chemotherapy or biologic therapy for recurrent/metastatic head and neck cancer
  • ✕Prior pemetrexed, bevacizumab, or other antiangiogenesis agents at any time
  • ✕Tumors that invaded major vessels
  • ✕Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment

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

Search/NCT00222729
NCT00222729Phase 2Completed
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Phase II Trial of Pemetrexed and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

University of Pittsburgh·interventional·Posted Sep 22, 2005·Updated Feb 15, 2016

In Brief

A Phase 2 clinical trial evaluating Pemetrexed and Bevacizumab for Cancer. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if the combination of two new drugs pemetrexed (Alimta) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Currently pemetrexed is approved by the Food and Drug Administration (FDA) for another type of cancer, mesothelioma, but it is not approved for head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer
CountriesUnited States
CollaboratorsEli Lilly and Company, Genentech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartNov 1, 2005
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 20.8 years ago

Interventions

Pemetrexeddrug

500 mg/m2 day 1 q 21 days

Bevacizumabdrug

15 mg/kg IV q 21 days following pemetrexed