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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


Phase 2
21 Years
70 Years
Open (Enrolling)
Female
Squamous Cell Carcinoma of the Cervix, Adenocarcinoma of the Cervix

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Trial Information

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


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 "

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

300CX02AR01

NCT ID:

NCT01639625

Start Date:

May 2011

Completion Date:

December 2014

Related Keywords:

  • Squamous Cell Carcinoma of the Cervix
  • Adenocarcinoma of the Cervix
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

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