At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of the head and neck, locally recurrent or metastatic
- ✓Measurable disease with baseline measurements obtained within 4 weeks of registration
- ✓May have had 0-1 prior chemotherapy regimen for recurrent or metastatic disease, completed ≥4 weeks prior to study entry
- ✓ECOG performance status 0 or 1
- ✕Prior treatment with irinotecan or bortezomib
- ✕Nasopharyngeal carcinoma WHO type II or III (only WHO type I allowed); salivary gland primaries excluded
- ✕Grade 2 or higher peripheral neuropathy within 2 weeks of study entry
- ✕Prior invasive malignancy unless disease-free interval ≥5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Two Arm Trial of the Proteasome Inhibitor, PS-341 (Velcade TM) in Combination With Irinotecan or PS-341 Alone Followed by the Addition of Irinotecan at Time of Progression in Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 2 clinical trial evaluating bortezomib, irinotecan hydrochloride, and 1 other intervention for Recurrent Squamous Cell Carcinoma of the Hypopharynx and 24 related conditions. Completed, enrolled 71 participants across 1 site.
Detailed Summary
This randomized phase II trial is studying bortezomib and irinotecan to see how well they work compared to bortezomib alone in treating patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with irinotecan may kill more tumor cells. It is not yet known whether giving bortezomib together with irinotecan is more effective than bortezomib alone in treating head and neck cancer.
Study Details
Timeline
Interventions
Given IV
Given IV
Optional correlative studies