Clinical trial

Bortezomib With or Without Irinotecan in Treating Patients With Locally…

NCT00103259 · National Cancer Institute (NCI), NIH · Completed

Key facts

NCT number NCT00103259
Title Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official title 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)
Lead sponsor National Cancer Institute (NCI), NIH
Status Completed
Phase Phase 2
Study type Interventional
Conditions Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx and 15 more
Intervention type Drug, Other
Interventions bortezomib, irinotecan hydrochloride, laboratory biomarker analysis
Enrollment 71
Start date Jul 1, 2005
Primary completion Nov 1, 2011
Completion Nov 1, 2011
First posted Feb 8, 2005
Last update posted May 23, 2014
Countries United States

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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