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

Sponsor

National Institute of Cancerología (Other)

Overall Status

Completed

CT.gov ID

NCT02095119

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Cancer	Drug: Nimotuzumab Drug: Cisplatin Drug: Gemcitabine Procedure: CT Scan	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I-II Study of Palliative Treatment With Nimotuzumab as a Second, Third Line or More of Treatment for Advanced or Metastatic Cervical Cancer

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Outcome Measures

Primary Outcome Measures

Antitumoral Response [After 4 weeks of induction therapy, and then every 3 months for a period of 2 years]
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.

Secondary Outcome Measures

Progression Free Survival [After patient´s inclusion every 3 months for a period 2 years]
Progression Free Survival will be defined as the time elapsed since the beginning of interventions until progressive disease is documented by growth of measurable lesions or new lesions on CT Scan or MRI according to the response evaluation criteria in solid tumors (JNCI 92 (3): 205-216, 2000).
Overall Survival [from patient´s inclusion until 24 months]
Patient´s survival since inclusion until death
Drug Toxicity [from patient´s inclusion every 2 weeks for a period of 2 years]
Drug toxicity will be assessed with hematologic, renal and hepatic laboratory measures as well as patient symptomatology and physical findings. Any abnormality in these parameters will be reported as an adverse event according to the Common Terminology Criteria for Adverse Events version 3.0(CTCAEV3.0, 2006)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Diagnostic criteria:

Female patients in whom a diagnosis of cervical cancer of epithelial origin has been confirmed by histologic and/or radiologic assessment.
Said patients must be in relapse or persistency after receiving first line chemo-radiotherapy and one or more lines of palliative chemotherapy.
Karnofsky score of 80 or more.
A CT scan will be performed in all patients to assess measurable target lesions.
The clinical diagnosis must be evaluated by more than clinical investigator

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.