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

Phase 2

Completed

• Conditions: Squamous Cell Carcinoma of the Cervix; Adenocarcinoma of the Cervix
• Interventions: Drug: CIGB300

• Registration Number: NCT01639625
• Lead Sponsor: Laboratorio Elea Phoenix S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-13
• Primary Completion: 2015-09
• Study Completion: 2016-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CIGB300	CIGB300	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of patients with local relapses	Up to 2 years
Number of patients with distant relapses	Up to 2 years

Trial Locations

Locations (1)

Instituto de Oncologia Angel H. Roffo; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina