Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

Summary

This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.

Timeline

Start

2006-02

Primary completion

2010-08

Completion

2010-08

Outcome

Missed primary endpoint

Stopped: “Study drug no longer available resulting in lack of study drug for participants.”

paper Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). PMID 24395863 ↗

paper TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS PMID 24395863 ↗

Publications

• DiSilvestro PA, Ali S, Craighead PS, Lucci JA, Lee YC, Cohn DE, Spirtos NM, Tewari KS, Muller C, Gajewski WH, Steinhoff MM, Monk BJ. Phase III randomized trial of weekly cisplatin and irradiation versus cisplatin and tirapazamine and irradiation in stages IB2, IIA, IIB, IIIB, and IVA cervical carcinoma limited to the pelvis: a Gynecologic Oncology Group study. J Clin Oncol. 2014 Feb 10;32(5):458-64. doi: 10.1200/JCO.2013.51.4265. Epub 2014 Jan 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	—	Intravenous
Subject	tirapazamine	Small molecule	—	Intravenous

Indications