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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
Sponsor:
Collaborators:
Pisa S.A de C.V
National Heart Institute, Mexico
Information provided by (Responsible Party):
Dr. Lucely Cetina Pérez, National Institute of Cancerología

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vinorelbine

Arm Intervention/treatment
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 Device: Placebo
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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 11 months ]
    Patient's survival since inclusion until death.


Secondary Outcome Measures :
  1. Illness free survival [ Time Frame: 6 months ]
    Patient´s survival will be evaluated from the moment of complete response until progression.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Mexico
National Institute of Cancerología
México, Tlalpan, Mexico, 14080
Sponsors and Collaborators
National Institute of Cancerología
Pisa S.A de C.V
National Heart Institute, Mexico
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Responsible Party: Dr. Lucely Cetina Pérez, MsC, MD, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT02083211    
Other Study ID Numbers: NIMO 001-09 MX
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Keywords provided by Dr. Lucely Cetina Pérez, National Institute of Cancerología:
Cervical cancer
Recurrent or persistent tumor
Monoclonal antibody
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents