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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorio Elea Phoenix S.A.; Laboratorio Elea S.A.C.I.F. y A.

Criteria

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 "