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

NCT01639625 | Completed Phase 2

• 1 other identifier: 300CX02AR01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of patients with local relapses

  Up to 2 years

• Number of patients with distant relapses

  Up to 2 years

Study Arms (1)

CIGB300

EXPERIMENTAL

Drug: CIGB300

Interventions

CIGB300 DRUG

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

CIGB300

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 "

Sponsors & Collaborators

• Laboratorio Elea Phoenix S.A.: lead

Study Sites (1)

Instituto de Oncologia Angel H. Roffo

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1417DTB, Argentina

Location

MeSH Terms

Interventions

CIGB-300

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: July 13, 2012
• Study Start: May 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 2, 2016

Record last verified: 2016-08

Locations

AR (1)