Combination of Nimotuzumab Cisplatin-Vinorelbine in First Line Chemotherapy in Recurring-Persistent Cervical Carcinoma
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|ClinicalTrials.gov Identifier: NCT02083211|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : April 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Recurrent or Persistent Palliative Treatment Monoclonal Antibody in Cervical Cancer Treatment||Drug: mAb Nimotuzumab Device: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase III Clinical Trial: "Evaluation of the Combination of Nimotuzumab and Cisplatin-Vinorelbine in First Line Chemotherapy in the Survival of Patients With Recurring-Persistent Cervical Carcinoma"|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||June 2014|
|Experimental: mAb Nimotuzumab + chemotherapy||
Drug: mAb Nimotuzumab
This group will receive a dose of 200 mg mAb hR3 (weekly over 18 weeks) plus chemotherapy (6 cycles every 21 days of Cisplatin (CDDP) 50 mg/m2 on day 1/, Vinorelbine 30 mg/m2 on day 1 and day 8)
|Placebo Comparator: placebo + chemotherapy||
This group will receive a placebo in addition to chemotherapy in a similar regimen. Once the chemotherapy is completed a maintenance dose will be administered with 200 mg/dose of mAb hR3 every 14 days until progression.
- Overall survival [ Time Frame: 11 months ]Patient's survival since inclusion until death.
- Illness free survival [ Time Frame: 6 months ]Patient´s survival will be evaluated from the moment of complete response until progression.
- Antitumoral Response [ Time Frame: 6 months ]Treatement response or progression will be evaluated according to the new International Criteria from Response Evaluation Committee in Solid Tumors (RECIST) (EJC 2009; 45: 228-247). Antitumoral response will be evaluated from patient´s inclusion after second and sixth quemoterapeutic line, and latter, every 3 months until second year of follow up for each patient.
- Progression free survival [ Time Frame: 3 months ]Time after treatment in wich illness remains unprogressive. It will be evaluated through antitumoral response on cycles 3 and 6 of first line chemotherapy, and on line 2 and every 3 months through first 2 years of follow up.
- Safety [ Time Frame: Every 2 weeks for a period of 3 years ]Safety will be evaluated according to occurrence of any adverse event (AE) on patients. AE will be described, including duration, treatment applied, intensity, causality relationship, attitude followed in the pace of the apparence of the AE and result of the treatment applied to counteract the AE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083211
|National Institute of Cancerología|
|México, Tlalpan, Mexico, 14080|