Combination of Nimotuzumab Cisplatin-Vinorelbine in First Line Chemotherapy in Recurring-Persistent Cervical Carcinoma
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
This study evauates the global survival of patients following administration of mAb
Nimotuzumab hR3 + chemotherapy in the treatment of cervical cancer in first line therapy,
after relapsing from chemo-radiotherapy.
It is a Phase III, multi-centric, randomized, double blind study; 168 patients will be
assigned to Nimotuzumab + Cisplatin/Vinorelbine or placebo + Cisplatin/Vinorelbine. After
progression, a second line chemotherapy based on carboplatino/taxol will be administered in
both groups. Concomitant administration of Nimotuzumab will be continued every 14 days until
limiting toxicity or ECOCG >3.
Tumor markers such as Kras, p53, KI67, and EGFR will be identified. Cardiac toxicity will be
evaluated using MRI.