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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02095119
Other study ID # INCAN/CC/130/09
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 17, 2014
Last updated April 13, 2015
Start date July 2008
Est. completion date March 2014

Study information

Verified date April 2015
Source National Institute of Cancerología
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Interventional

Clinical Trial Summary

The following is an open label, non comparative, pilot study of palliative treatment as a second, third line or more of treatment in patients with recurrent, persistent or Metastatic Cervical Cancer; it has a limited sample of 15 patients with the primary goal of evaluating the response (defined as: Complete, partial or stable disease) to treatment with a Monoclonal Antibody, Nimotuzumab, on a weekly basis + CDDP 50mg/m2/BSA as a single agent every 3 weeks for patients with good renal function (Creatinine clearance => 60) or Gemcitabine 800 mg/m2/BSA in patients with renal failure (Creatinine clearance <60).

Secondary objectives consist of evaluating disease-free survival, overall survival and assess patient tolerance to treatment with Nimotuzumab.


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Study Design

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


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Mexico Instituto Nacional de Cancerología Mexico City Federal District

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Cancerología

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antitumoral Response Treatment response will be evaluated according to the new International Criteria from Response Evaluation Committee in Solid Tumors (RESIST). Antitumoral response will be evaluated from patient´s inclusion after 4 weeks of induction therapy and then every 3 months until second year of follow up for each patient. After 4 weeks of induction therapy, and then every 3 months for a period of 2 years No
Secondary Progression Free Survival Progression Free Survival will be defined as the time elapsed since the beginning of interventions until progressive disease is documented by growth of measurable lesions or new lesions on CT Scan or MRI according to the response evaluation criteria in solid tumors (JNCI 92 (3): 205-216, 2000). After patient´s inclusion every 3 months for a period 2 years No
Secondary Overall Survival Patient´s survival since inclusion until death from patient´s inclusion until 24 months No
Secondary Drug Toxicity Drug toxicity will be assessed with hematologic, renal and hepatic laboratory measures as well as patient symptomatology and physical findings. Any abnormality in these parameters will be reported as an adverse event according to the Common Terminology Criteria for Adverse Events version 3.0(CTCAEV3.0, 2006) from patient´s inclusion every 2 weeks for a period of 2 years Yes
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