US-based Nanotherapeutics has started patient enrolment in a Phase II cervical cancer trial of Triapine, a ribonucleotidereductase inhibitor (RNRi) currently under evaluation in combination with cisplatin and radiation as a radiosensitising chemotherapeutic agent for women with advanced stage cervical/ vaginal cancers.
The double-blinded, randomised, multi-centre trial is sponsored by National Cancer Institute (NCI)'s Division of Cancer Treatment and Diagnosis (DCTD), as part of the clinical trials agreement between NCI and Nanotherapeutics.
A total of 73 women with advanced stage cervical/vaginal cancer will be enrolled in the trial, which will investigate cisplatin and radiation therapy, with or without Triapine.
The trial will be carried out at more than six medical centres in the US and the enrolled patients will have previously untreated stage IB-IVA cervical cancer or stage II-IVA vaginal cancer.
The primary endpoint of the trial will be a metabolic response captured by the three month post-therapy 18-fludeoxyglucose (18F-FDG) PET/CT response, while the secondary endpoint will include adverse events as well as clinical response as measured by RECIST (Response Evaluation Criteria In Solid Tumors) criteria and progression-free survival.
According to the company, the trial is scheduled to be complete in 2014.
Nanotherapeutics chief medical officer Carl Kraus said about 50% of the over 12,000 women in the US are diagnosed annually with cervical/vaginal cancer present with non-localised disease.
"Additional therapeutic options are needed for this group, and we are hopeful that Triapine may positively impact the natural history of this disease for these women," Kraus said.
According to a previously conducted Phase II trial in 25 subjects, Triapine in conjunction with cisplatin and radiation demonstrated a 100% complete response rate with no disease progression that was documented through 18 months of median follow-up.
The company expects that when completed, the latest Phase II trial will provide the necessary data for a larger confirmatory trial.
Image: Micrograph of a (cervical) adenosquamous carcinoma, a type of cervical cancer. Photo: courtesy of Nephron.