Evaluate Efficacy of the Association Nimotuzumab(HR3) /Cisplatin-Vinorelbine on Patients With Cervical Carcinom

• Register: ClinicalTrials.gov
• Last refreshed on: 30 August 2021
• Main ID: NCT03413579
• Date of registration: 11/01/2018
• Prospective Registration: No
• Primary sponsor: El Kendi Pharmaceuticals Manufacturing Company
• Public title: Evaluate Efficacy of the Association Nimotuzumab(HR3) /Cisplatin-Vinorelbine on Patients With Cervical Carcinom CIMAHOPE
• Scientific title: Multicenter Randomised Double-blind Study to Compare HR3 or Placebo in Combination With Cisplatin-navelbine for Patients With Cervical Carcinoma, Followed in Case of Progression by a Second Line.
• Date of first enrolment: November 2015
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03413579
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Algeria

Contacts

• Name: Mohamed MECHETI, MD.
• Affiliation: El Kendi, Part of MS Pharma, Manufacturing Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients aged between 18 to 75, including both limits.

- Patients who give their written consent to participate to the study.

- Chemonaive patients with local cervical cancer and / or persistent or recurrent
metastatic disease with measurable disease (RECIST criteria) by a physical examination
(scanner or MRI).

A confirmation by biopsy is necessary in case there is a single lesion less than 2 cm.

- Patients who had pelvic CT + radiotherapy may also be included in the study
(concomitant chemotherapy as a radiotherapy stabilizer).

- Patients having a histopathological report: epidermoid carcinoma, adenocarcinoma,
adenosquamous carcinoma and / or clear cells carcinoma.

- Patients with an ECOG score between 0-2

- Patients with a life expectancy greater than six months.

- Patients with Left Ventricular Ejection Fraction (LVEF) =50%, through
Echocardiography.

- Patients with normal function of organs and bone marrow, defined by the following
parameters:

- Haemoglobin = 9 g / dL

- White Blood cell = 4000 /mm3

- Absolute neutrophil count= 1500 /mm3

- Platelet count= 100000 /mm3

- Total bilirubin up to 1.5 the upper limit of normal (ULN)

- Albumin = 2 g/dL (3,5 - 5,0 g /dl)

- Serum Glutamopyruvate Transférase (SGPT) and SErum Glutamooxaloacetate
Transferase (SGTO) < or = 2.5 ULN

- Serum creatinine within the normal limits and the calculation of glomerular
filtration according to Cockcroft formula = 60ml and according to MDRD formula
for patients whose age is 70 years = 60ml . Glomerular filtration will be
performed only on clinical discretion for patients suspected to have a kidney
problem. (The normal laboratory values will be appropriate to the techniques and
equipment used in the place where they are done).

- The determination or expression of EGF-R (epidermal growth factor receptor), p53, Ki67
and Bcl-2 by immuno-histochemistry in the primary tumor before treatment integrated in
a paraffin block.

The results are not an inclusion criterion, but will be evaluated as an indicator of
prognostic response in the final assessment.

Exclusion Criteria:

- Pregnant or breastfeeding patients

- Patients with small cells and / or neuroendocrine cervical cancer.

- Patients receiving another onco-specific drug, for other clinical trial,

- Patients with a history of allergy attributed to chemical or biological compounds
similar to the monoclonal antibody being evaluated or to chemotherapeutic agents.

- Patients having uncontrolled intercurrent diseases, including active infections,
symptomatic congestive heart failure , unstable angina, cardiac arrhythmia,
decompensated diabetes, uncontrolled hypertension and psychiatric disorders.

- Patients having a second tumor . Excepting for those receiving appropriate therapy for
skin cancer (basal or squamous)

- Previous or concomitant malignancy with exception for non-melanoma skin carcinomas

- Patients having special conditions or circumstances that could significantly limit the
complete follow up of the study



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Biological: Nimotuzumab ( h-R3)

Other: Placebo

Primary Outcome(s)

Overall survival in patients who received hR3 mAb treatment combined with Chemotherapy [Time Frame: Calculated from patient randomisation to death (36 months)]

Secondary Outcome(s)

Antitumor Response [Time Frame: up to 24months (every 3 months)]

Duration of response [Time Frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]

Progression-free survival [Time Frame: Time from randomization until disease progression or death, assessed up to 60 months]

Time to progression [Time Frame: Time from randomization until objective tumor progression assessed up to 60 months]

Secondary ID(s)

CIMA-I3-05D143-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors