CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
gemcitabine +1 moredrug
Likely dose
Gemcitabine 3,000 mg/m² IV over 30 minutes on days 1 and 15 (q28 days); Paclitaxel 150 mg/m² IV over 1 hour on days 1 and 15 (q28 days)AI-extracted
Key inclusion· 5
  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) with recurrent, persistent, or newly diagnosed metastatic disease
  • Measurable or non-measurable disease
  • Age 18 years or older
  • Zubrod performance status 0-1
Key exclusion· 8
  • Active or prior CNS metastasis
  • Symptomatic sensory neuropathy grade 2 or higher
  • History of hypersensitivity reaction to products containing polysorbate 80
  • Active infection requiring systemic antibiotic therapy

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

Search/NCT00100789
NCT00100789Phase 2Completed

A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

SWOG Cancer Research Network·interventional·Posted Jan 7, 2005·Updated Oct 1, 2012

In Brief

A Phase 2 clinical trial evaluating gemcitabine and paclitaxel for Head and Neck Cancer. Completed, enrolled 67 participants across 123 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 7, 2005
Enrollment StartJan 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 21.5 years ago

Interventions

gemcitabinedrug

3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).

paclitaxeldrug

150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine