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

NCT02095119 | Completed Phase 1 DMC

• 1 other identifier: INCAN/CC/130/09
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Uterine cervical cancer; Palliative; Treatment; Monoclonal antibody; Nimotuzumab

Outcome Measures

Primary Outcomes (1)

• Antitumoral Response

  Treatment response will be evaluated according to the new International Criteria from Response Evaluation Committee in Solid Tumors (RESIST). Antitumoral response will be evaluated from patient´s inclusion after 4 weeks of induction therapy and then every 3 months until second year of follow up for each patient.

  After 4 weeks of induction therapy, and then every 3 months for a period of 2 years

Secondary Outcomes (3)

• Progression Free Survival

  After patient´s inclusion every 3 months for a period 2 years

• Overall Survival

  from patient´s inclusion until 24 months

• Drug Toxicity

  from patient´s inclusion every 2 weeks for a period of 2 years

Interventions

Nimotuzumab DRUG

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.

Cisplatin DRUG

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.

Gemcitabine DRUG

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.

CT Scan PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, Federal District, 14080, Mexico

Location

Related Publications (1)

• 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.

  PMID: 25802932 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

nimotuzumab; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lucely Cetina, MD

  Researcher Level D

  PRINCIPAL INVESTIGATOR

• Sergio A. Zapata, MD

  Instituto Nacional de Cancerologia de Mexico

  STUDY CHAIR

• Roberto Jimenez, MD

  Instituto Nacional de Cancerologia de Mexico

  STUDY CHAIR

• Tania Crombert, MD

  Centro Molecular de La Habana

  STUDY CHAIR

• Mayra Ramos, MD

  Centro Molecular de La Habana

  STUDY CHAIR

• Ezequiel Fuentes, MD

  Pisa® Farmacéutica

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC, MD

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: March 24, 2014
• Study Start: July 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

ME (1)