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

Laboratorio Elea

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma of the Cervix; Squamous Cell Carcinoma of the Cervix

Treatments: Drug: CIGB300

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639625

300CX02AR01

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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 "

Trial design

18 participants in 1 patient group

CIGB300

Experimental group

Treatment:

Drug: CIGB300