Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application
Study Details
Study Description
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 |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CIGB300
|
Drug: CIGB300
CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of patients with local relapses [Up to 2 years]
- Number of patients with distant relapses [Up to 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stages IIA and IIB FIGO classification.
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Age between 21 to 70 years.
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ECOG performance status 0-1.
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No history of another neoplastic disease.
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Value of Hemoglobin ≥ 9 g / l.
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Total leukocyte count ≥ 3.0 x 109 / L.
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Absolute neutrophil count ≥ 1.5 x 109 / L.
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Platelets ≥ 100,000 x mm3.
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Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal.
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Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula)
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Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy.
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Life expectancy ≥ 12 months
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Measurable disease
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Informed consent signed by the patient
Exclusion Criteria:
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Pregnancy and lactation period.
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Presence of lymph node metastases or hematogenous extrapelvic known.
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Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.
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Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years.
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Hepatitis B or C active, positive serology for HIV.
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Atopy history of severe / severe asthma.
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A history of autoimmune disease.
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Presence of significant abnormalities in ECG performed within 14 days prior to admission.
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Diseases that prevent the patient give informed consent or their ability to collaborate in the trial.
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Participating in another clinical trial "
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Instituto de Oncologia Angel H. Roffo | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | C1417DTB |
Sponsors and Collaborators
- Laboratorio Elea Phoenix S.A.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 300CX02AR01