A Monoclonal Antibody, Nimotuzumab, as Treatment for Recurrent or Metastatic Cervical Cancer

NCT ID: NCT02095119

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2014-03-31

Brief Summary

The following is an open label, non comparative, pilot study of palliative treatment as a second, third line or more of treatment in patients with recurrent, persistent or Metastatic Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800 mg/m2/BSA in patients with renal failure (Creatinine clearance <60).

Secondary objectives consist of evaluating disease-free survival, overall survival and assess patient tolerance to treatment with Nimotuzumab.

Conditions

Uterine Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Nimotuzumab

Monoclonal antibody Nimotuzumab will be administered alone at a 200mg dose weekly during the first 4 weeks. Posteriorly it will be administered with a maintenance dose of 200 mg every 2 weeks in combination with chemotherapeutic agents Cisplatin in patients with good renal function or Gemcitabine in patients with kidney failure data until exclusion or death occurs. The administration will be intravenously in 250 ml of saline solution in a time period of 30 minutes.

Intervention Type: DRUG

Cisplatin

Cisplatin will be administered at a calculated dose of 50mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, only in patients whose creatinine clearance as defined by the Cockcroft-Gault equation is \>/= 60. The administration form will be intravenously.

Intervention Type: DRUG

Gemcitabine

Gemcitabine will be administered at a calculated dose of 800 mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, in patients with kidney failure data(Creatinine clearance as defined by the Cockcroft -Gault equation \< 60). The administration form will be intravenously.

Intervention Type: DRUG

CT Scan

A CT Scan will be performed in all patients prior to the beginning of treatment to assess any measurable tumor found by this method. The CT Scan will be repeated once the patient completes the induction phase with Nimotuzumab (4 once a week doses), when the patient has completed 3 full cycles of combination therapy with Nimotuzumab (every 2 weeks)and Gemcitabine or Cisplatin (every 21 days)and once more when the patient has completed 6 full cycles of the aforementioned therapy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who give their written consent of participation in this study.
• Patients with recurrent or persistent cervical-uterine cancer, with local and/or systemic disease with measurable lesions, whether by physical examination, CT Scan or MRI detected at least in the previous 6 weeks. If there is only one lesion and it is less than 10 mm in length, a biopsy confirmation is required.
• Patients currently receiving a second, third line or more of palliative chemotherapy diagnosed at least 30 days after the last chemotherapy.
• Patients with one of the following Histopathological reports: Squamous Cell Carcinoma (epidermoid carcinoma), adenocarcinoma, adenosquamous carcinoma or glassy cell carcinoma.
• Patients must be older than 18 years old.
• ECOG score no worst than 3.
• Patients with life expectancy greater than 4 weeks.
• Patients with left ventricle ejection fraction (LVEF) ≥ 50 measured by radioisotopic ventriculography.
• Patients who meet all previous criteria with previously radiated metastatic disease in the central nervous system will be included.
• Patients with normal functioning of the bone marrow and other organs as defined by the following parameters:
• Hemoglobin ≥ 9 g/L
• Leucocytes ≥ 4000/microL
• Absolute neutrophil count ≥ 1500/microL
• Platelet count ≥ 100000/microL
• Total serum Bilirubin: up to 1.5 times the normal value
• Total Proteins: Within normal limits
• AST and ALT =/< 2.5 times the normal superior limit of the institutional laboratory
• Serum creatinine: within normal limits or up to 2 mg and GFR ≥ 60ml/min calculated with the Cockcroft-Gault equation.

Exclusion Criteria

• Pregnant or nursing mothers.
• Patients with cervical-uterine cancer with a histopathological report of: small cell carcinoma and/or neuroendocrine tumor.
• Patients currently receiving another investigational onco-specific drug.
• Patients with a history of allergy to chemical substances with similar chemical composition to that of the monoclonal antibody or chemotherapeutic agents used in this study.
• Patients with non-controlled co-morbid states such as active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, uncompensated diabetes and/or psychiatric illness.
• Presence of a second tumor. With the exception of those patients who have received adequate treatment for skin carcinomas (basal or squamous).
• Previous or concomitant malignancy except non-melanoma skin carcinoma.
• Social, familiar or geographic conditions that suggest poor attachment to the study.

Discontinuation of treatment criteria:

• At the patient´s request.
• Progression of disease causing worsening of the patient´s overall status in non manageable clinical conditions, (ECOG worst than 3).
• Death.
• Discontinuation of monitoring and/or loss of patient follow-up for more than 2 months.
• Severe adverse reaction grade 4 according to CTCAE.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cancerología

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Lucely Cetina Pérez

MsC, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucely Cetina, MD

Role: PRINCIPAL_INVESTIGATOR

Researcher Level D

Sergio A. Zapata, MD

Role: STUDY_CHAIR

Instituto Nacional de Cancerologia de Mexico

Roberto Jimenez, MD

Role: STUDY_CHAIR

Instituto Nacional de Cancerologia de Mexico

Tania Crombert, MD

Role: STUDY_CHAIR

Centro Molecular de La Habana

Mayra Ramos, MD

Role: STUDY_CHAIR

Centro Molecular de La Habana

Ezequiel Fuentes, MD

Role: STUDY_CHAIR

Pisa® Farmacéutica

Locations

Instituto Nacional de Cancerología

Mexico City, Federal District, Mexico

Countries

Mexico

References

Cetina L, Crombet T, Jimenez-Lima R, Zapata S, Ramos M, Avila S, Coronel J, Charco E, Bojalil R, Astudillo H, Bazan B, Duenas-Gonzalez A. A pilot study of nimotuzumab plus single agent chemotherapy as second- or third-line treatment or more in patients with recurrent, persistent or metastatic cervical cancer. Cancer Biol Ther. 2015;16(5):684-9. doi: 10.1080/15384047.2015.1026483.

Reference Type: DERIVED

PMID: 25802932 (View on PubMed)

Other Identifiers

INCAN/CC/130/09

Identifier Type: -

Identifier Source: org_study_id