Combination of Nimotuzumab Cisplatin-Vinorelbine in First Line Chemotherapy in Recurring-Persistent Cervical Carcinoma

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cancerología
• Collaborators: National Heart Institute, Mexico; Pisa S.A de C.V
• Treatments: Cisplatin; Nimotuzumab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Patients who grant their written consent to participate in the trial;

• With persistent or recurrent local and/or systemic cervical cancer with a measurable disease through physical examination, CAT, or MRI;

• Diagnosed 90 days after concluding administration of chemotherapy + radotherapy to pelvis or pelvic extended fields chemo-radiotherapy;

• Pathological report with epidermal carcinoma, adenocarcinoma, adenosquamous carcinoma and glassy cell carcinoma;

• ECOG Performance Status ≤2;

• Life expectancy >6 months;

• LVEF >50 (MUGA or ecocardiogram)

• Normal function of organs and of bone marrow defined by laboratory parameters.

Exclusion Criteria:

• Pregnant or breastfeeding patients;

• Small cells and/or neuroendocrine cervical cancer;

• Receiving other oncospecific drug under research;

• Allergy history to compounds of chemical or biological similar composition to the monoclonal antibody being evaluated or to chemotherapeutic agents;

• Intercurrent non controlled diseases including active infections, symptomatic congestive cardiac failure, unstable angina pectoris, cardiac arrhythmia, decompensated diabetes and psychiatric disorders.

• With a second tumor; except for those who have received appropriate treatment for skin carcinomas (basal or squamous).

• Previous or concomitant malignancy except for non-melanoma skin carcinoma.

• Social, family or geographic conditions that suggest a poor study compliance.