Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application

Squamous Cell Carcinoma of the Cervix Clinical Trial

Official title:

Open Clinical Trial, Uncontrolled in Patients Bearing Squamous Cell Carcinoma or Adenocarcinoma of the Cervix Stage IIA and IIB FIGO Classification Treated With Radiotherapy External Endocavitary Brachytherapy + Concurrent Hemotherapy Weekly Systemic and Local Application of CIGB-300 Dose Escalation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639625
• Other study ID #: 300CX02AR01
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2012
• Last updated: August 1, 2016
• Start date: May 2011
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: Laboratorio Elea S.A.C.I.F. y A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Stages IIA and IIB FIGO classification.

• Age between 21 to 70 years.

• ECOG performance status 0-1.

• No history of another neoplastic disease.

• Value of Hemoglobin = 9 g / l.

• Total leukocyte count = 3.0 x 109 / L.

• Absolute neutrophil count = 1.5 x 109 / L.

• Platelets = 100,000 x mm3.

• Total bilirubin = 1.5 times ULN, SGOT and SGPT = 2.5 times upper limit of normal.

• Creatinine = 2 mg / dL and creatinine clearance calculated = 60 ml / min(according to Cockcroft-Gault formula)

• Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy.

• Life expectancy = 12 months

• Measurable disease

• Informed consent signed by the patient

Exclusion Criteria:

• Pregnancy and lactation period.

• Presence of lymph node metastases or hematogenous extrapelvic known.

• Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.

• Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period = 5 years.

• Hepatitis B or C active, positive serology for HIV.

• Atopy history of severe / severe asthma.

• A history of autoimmune disease.

• Presence of significant abnormalities in ECG performed within 14 days prior to admission.

• Diseases that prevent the patient give informed consent or their ability to collaborate in the trial.

• Participating in another clinical trial "

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Cervix
• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of the Cervix

Intervention

Drug:
• CIGB300
CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.

Locations

Country	Name	City	State
Argentina	Instituto de Oncologia Angel H. Roffo	Ciudad Autonoma de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorio Elea S.A.C.I.F. y A.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level		Up to 2 years	Yes
Secondary	Number of patients with local relapses		Up to 2 years	No
Secondary	Number of patients with distant relapses		Up to 2 years	No