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

NCT ID: NCT01639625

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2016-01-31

Brief Summary

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

Conditions

Squamous Cell Carcinoma of the Cervix; Adenocarcinoma of the Cervix

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

CIGB300

Group Type: EXPERIMENTAL

CIGB300

Intervention Type: DRUG

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

Interventions

CIGB300

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

Intervention Type: DRUG

Eligibility 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 "

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Laboratorio Elea Phoenix S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Instituto de Oncologia Angel H. Roffo

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Countries

Argentina

Other Identifiers

300CX02AR01

Identifier Type: -

Identifier Source: org_study_id