Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 2 Completed 63 enrolled Stanford University National Cancer Institute (NCI) · collab

RandomizedParallel-groupTreatment

Summary

PURPOSE: Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (RT + cisplatin + 5-FU) with or without tirapazamine for the treatment of patients with stage III or IV squamous cell carcinomas of the head and neck cancer (SCCHN). RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.

Timeline

Start: 1996-06
Primary completion: 2000-06
Completion: 2005-06

Outcome

Missed primary endpoint

paper 90% and 74% for the standard treatment arm and the TPZ arm, respectively (P = .08) PMID 16532436 ↗

Publications

Results Le QT, Taira A, Budenz S, Jo Dorie M, Goffinet DR, Fee WE, Goode R, Bloch D, Koong A, Martin Brown J, Pinto HA. Mature results from a randomized Phase II trial of cisplatin plus 5-fluorouracil and radiotherapy with or without tirapazamine in patients with resectable Stage IV head and neck squamous cell carcinomas. Cancer. 2006 May 1;106(9):1940-9. doi: 10.1002/cncr.21785.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tirapazamine	Small molecule	160 mg/m2	Other
Subject	tirapazamine	Small molecule	220 mg/m2	Other
Subject	tirapazamine	Small molecule	260 mg/m2	Other
Background	Cisplatin	Other / unclassified	20 mg/m2	Intravenous
Background	fluorouracil	Small molecule	600 mg/m2	Other