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

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ClinicalTrials.gov Identifier: NCT01639625
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Laboratorio Elea S.A.C.I.F. y A.

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Cervix Adenocarcinoma of the Cervix Drug: CIGB300 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : May 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: CIGB300 Drug: CIGB300
CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.




Primary Outcome Measures :
  1. Number of patients with presence or absence of grade 3 or 4 adverse events related to the study drug, in each dose level [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Number of patients with local relapses [ Time Frame: Up to 2 years ]
  2. Number of patients with distant relapses [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 "

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639625


Locations
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Argentina
Instituto de Oncologia Angel H. Roffo
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1417DTB
Sponsors and Collaborators
Laboratorio Elea S.A.C.I.F. y A.

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Responsible Party: Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier: NCT01639625     History of Changes
Other Study ID Numbers: 300CX02AR01
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell