Clinical trial NCT01639625: Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Cervix
Adenocarcinoma of the Cervix
Lead sponsor: Laboratorio Elea Phoenix S.A.
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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


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 "

Primary outcomes:
measure: Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of patients with local relapses
timeFrame: Up to 2 years
measure: Number of patients with distant relapses
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Oncologia Angel H. Roffo
state: Buenos Aires
Study officials:
References: