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

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

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

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of the Cervix; Adenocarcinoma of the Cervix
• Intervention / Treatment: Drug: CIGB300

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1417DTB
      • Instituto de Oncología Ángel H. Roffo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CIGB300	Drug: CIGB300; CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Number of patients with local relapses	Up to 2 years
Number of patients with distant relapses	Up to 2 years

Collaborators and Investigators

• Sponsor: Laboratorio Elea Phoenix S.A.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: June 15, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (ESTIMATE): July 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Adenocarcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: 300CX02AR01