Nimotuzumab- Head and neck cancer

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000089
• Date of registration: 22/10/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: Nimotuzumab- Head and neck cancer
• Scientific title: Using the monoclonal antibody Nimotuzumab in treating patients with squamous cell carcinoma of head and neck in advanced stages.
• Date of first enrolment: 06/01/2009
• Target sample size: Inclusion of 3 years.
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000089-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Treatment Other design features: 5 treatment schemes with Nimotuzumab

Countries of recruitment

Cuba

Contacts

• Name: Patricia MD. Piedra
• Affiliation: CIMAB SA.

• Name: Patricia MD. Piedra
• Affiliation: CIMAB SA.

Key inclusion & exclusion criteria

Inclusion criteria: 1.Age greater than or equal to 18 years. 2.Life expectancy of at least 12 weeks. 3.General status ECOG 0-2. 4.Patients give their consent to participate in the study in writing.
Exclusion criteria: 1.Patient at the time of inclusion is receiving another investigational drug. 2.Pregnancy,postpartum or breastfeeding. 3.History of hypersensitivity to any of the components of the pharmaceutical formulation of Nimotuzumab. 4.Presence of a second primary tumor, except basal or squamous cell carcinoma of the skin and neck carcinoma in situ treated.

Age minimum: 18 years
Age maximum: none
Gender: Both

Health Condition(s) or Problem(s) studied

Squamous cell carcinoma of head and neck in advanced stages.

Intervention(s)

Treatment schemes: 1.Schedule A:Nimotuzumab + RT 2.Schedule B:Nimotuzumab + RT + CT,concurrent 3.Schedule C:Nimotuzumab + RT + CT,sequential 4.Scheme D:Monotherapy with Nimotuzumab 5.Scheme E: Nimotuzumab + CT Nimotuzumab Indication: 200 mg intravenous infusion (IV),(30-60 minutes,diluted in 250 ml 0.9% NaCl) Induction phase:,1 time/week for 6 weeks. Maintenance phase: every 21 days until discontinuation of treatment (IT) for at least one of the causes provided in the protocol. Indication of radiotherapy(RT): Dose:66 Gy Scheme may involve Co60, linear accelerator or fractionated 2 Gy/day,1-5 days a week (Monday-Friday) until doses indicated. Indication of Chemotherapy(CT):Cisplatin 100 mg/m2 intravenous(EV) + 5-FU 1000 mg/m2. Frequency and Duration of Treatment: Concurrent treatment: days 1, 22 and 43 Sequential treatment:Cisplatin days 1, 5-FU days 1-4 (Monday-Thursday) every 3 to 4 weeks for 3 cycles.

Primary Outcome(s)

Incidence of Adverse Events (AE) relating to the administration of Nimotuzumab (AE with causal relationship probable or very likely). Measuring time: every three months until to complete 2 years of treatment.

Secondary Outcome(s)

Clinical Response (Objective response and Antitumor Clinical Response). Measuring Time: every 3 months until to complete 2 years of treatment. - Objective response (Measurable disease and No measurable disease) - Measurable disease (Complete Response,Partial Response,No change,Progression), - No measurable disease (Complete Response, Partial Response, Stabilization, Progression) - Antitumor Clinical Response(Complete Response, Partial Response, Progressive Disease, Stable disease) Progression-free survival (PFS). Time in months from inclusion date until it objectively documented progressive disease or death. Measuring time: 2 years of treatment or progression date or death date. Global Survival. Time in months from the inclusion date until death or last date you have news. Measurement time: 2 years of treatment or death. Quality of Life (Quality of Life Questionnaire EORTC QLQ-C30 (version 3) and QLQ-H&N35 (version 3) ). Measuring Time: every 3 months until to complete 2 years of treatment. Adverse events (AE). Measuring Time: 2 years of treatment. - Type of AE (name of the adverse event) - Time between the time of administration and the occurrence of AE (hours and minutes or days) - Duration of AE (Difference between of start date and the end date of the AE. May be in days, hours or minutes) - Serious AE (Severe/Serious, not serious/not serious) - Intensity of AE (Grade 1:Slight, Grade 2:Moderate, Grade 3:Severe, Grade 4:Danger to life, Grade 5:Death) - Causal relationship (Remote, possible, probable, very likely) accordint to FDA criteria - Possible causal treatment (name of treatment that provo, if one considers that the AE is due to the administration Nimotuzumab or the QT and/or RT or other concomitant treatment) - Attitude from study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) - Result of AE (recovered, improved, persist, sequelae)

Secondary ID(s)

IIC RD-EC0113

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable