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

CompletadoFase 2ClinicalTrials.gov

ID: NCT01639625Tipo: INTERVENTIONALInicio: 1 de may de 2011Fin estimado: 1 de ene de 2016

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 21 YearsEdad máxima: 70 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

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 "

Intervenciones

drug

CIGB300

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

Ubicaciones

Instituto de Oncologia Angel H. Roffo

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalLaboratorio Elea Phoenix S.A.

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