Status:
COMPLETED
Evaluate Efficacy of the Association Nimotuzumab(HR3) /Cisplatin-Vinorelbine on Patients With Cervical Carcinom
Lead Sponsor:
El Kendi Pharmaceuticals Manufacturing Company
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 chem...
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 patien...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03413579
Start Date
November 1 2015
End Date
February 1 2021
Last Update
August 25 2021
Active Locations (5)
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1
Centre Pierre et Marie Curie (CPMC)
Algiers, Algeria
2
CAC Annaba
Annaba, Algeria
3
CAC Batna
Batna City, Algeria
4
CHU Frantz Fanon
Blida, Algeria