Evaluate Efficacy of the Association Nimotuzumab(HR3) /Cisplatin-Vinorelbine on Patients With Cervical Carcinom
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the present study is to estimate the overall survival of patients with
      cervical cancer after the administration of monoclonal antibody (mAb) Nimotuzumab (hR3) in
      combination with chemotherapy of first intention. Patients will be randomized in two parallel
      treatment groups. The first group will receive a dose of 200 mg of monoclonal antibody
      anti-hR3 (weekly during 18 weeks), combined with a chemotherapy (6 cycles, every 21 days of
      Cisplatin 70mg/m2, Vinorelbine 60 mg/m2 (Per Os) at D1 and D8 and then 80mg / m2. The second
      group will receive a placebo in combination with the same chemotherapy regimen as the first
      group.

      At the end of the first intention chemotherapy treatment, a dose of maintenance of
      Nimotuzumab will be administered at the dose of 200mg every 14 days until progression. A
      second chemotherapy in the second intention is proposed, this one is based on Carboplatin (
      CBP) in an AUC (area under curve) of 6, and Paclitaxel (Txl) in 175 mg / m2 / BSA (body
      surface area ) in drip of 3 hours, every 3 weeks, concomitant with the administration of hR3,
      every 14 days, until a limit of toxicity or an ECOG (Eastern Cooperative Oncology Group)
      status superior to 3, appears.
    

Detailed description: 
      The objective of the present study is to assess the overall survival of patients after
      administration of Nimotuzumab hR3 monoclonal antibodies (combined with a chemotherapy) in the
      treatment of patients with cervix epithelial tumors as first-line treatment.

      The patients included will be divided into two treatment groups. The first group receive a
      200 mg dose of hR3 monoclonal antibody (weekly for 18 weeks), and chemotherapy (6 cycles,
      every 21 days: Cisplatin (CDDP) 70 mg / m2 on day 1, Vinorelbine 60 mg / m2 on day 1 and day
      8) and then 80mg / m2. The second group receive a placebo in addition to the listed
      chemotherapy.

      After the first line , a 200mg dose of hR3 monoclonal antibodies will be given every 14 days
      until progress.

      A second -line chemotherapy is proposed, this is based on Carboplatin (CBP) at AUC of 6, and
      Paclitaxel (Txl) 175 mg / m2 / SC as 3 hour infusion, every 3 weeks, concomitant with the
      administration of hR3, every 14 days, until a toxicity limit or an ECOG status greater than 3
      appears.

      The survival overall will be considered as the main variable of the response and survival
      without progression from the antitumor response, the toxicity assessment and the quality of
      life will be the secondary variables. In addition, the effects may arise during treatment
      will be identified, and tumor biopsy markers such as, EGF-R and HPV will be determined and
      those of p53, Ki67 and Bcl-2 by immunohistochemistry (IHC).

      It is expected to achieve a difference in survival between the treatment groups of 6.5 vs
      10.5 months (0.278 vs 0.62) in favor of the group with mAb hR3.
    

Intervention name(s): Nimotuzumab ( h-R3); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Humanized monoclonal antibody
Other intervention name(s): CIMAHOPE
Intervention MeSH terms: Nimotuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cervix; Oncology,; hR3,; Nimotuzumab,; Chemotherapy,; Survival; Monoclonal antibody; RECIST; Cisplatin; Vinorelbine; Paclitaxel; Carboplatine; Randomisation; Placebo; cancer; cimahope