Nimotuzumab- Head and neck cancer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Using the monoclonal antibody Nimotuzumab in treating patients with squamous cell carcinoma of head and neck in advanced stages.

Secondary indentifying numbers:

IIC RD-EC0113

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Government funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

26/12/2008

Reference number:

24-081-08-B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria de los Angeles Reynaldo Gonzalez, MD.Second degree specialist in Otorhinolaryngology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana City, “Hermanos Ameijeiras Hospital", MD. Tamara Correa Pablos, First degree specialist in Radiology. Havana City, "Research Center for Medical-Surgical (CIMEQ)", MD.Ilsa Garcia Estrada, First degree specialist in Otorhinolaryngology. Havana City, "National Institute of Oncology and Radiobiology" (INOR), MD. Iván Cuevas Veliz, First degree specialist in Oncology. Havana City, “Enrique Cabrera” Hospital, MD. Vladimir Tomás Pérez Báez, First degree specialist in Otorhinolaryngology. Pinar del Rio, “III Congreso” Hospital, MD. Roberto Lucio Lazo Carrera, Second degree specialist in Oncology. Villa Clara, “Celestino Hernandez Robau” Hospital, MD. Julio Hernandez Cruz, First degree specialist in Oncology. Cienfuegos, “Gustavo Aldereguia Lima Hospital”, MD. Luis Alfonso Varona Vazquez, First degree specialist in Oncology Camaguey, “Maria Curie” Hospital, MD. Lisandro Vila Martinez, First degree specialist in Otorhinolaryngology. Las Tunas, “Ernesto Guevara” Hospital, MD. Ramón Leon Polanco. First degree specialist in Oncology Santiago de Cuba, “Conrado Benitez” Hospital, MD. Justo Despaigne Delisle. Second degree specialist in Surgery. Granma, “Celia Sanchez Manduley”. MD. Gustavo Enrique Pich Marti. First degree specialist in Oncology Guantánamo, “Agostinho Neto” Hospital. MD. Neudis Simón Duvergel. First degree specialist in Oncology

Research ethics committees:

Havana City, “Hermanos Ameijeiras Hospital”, December 8, 2008. Havana City, ”Research Center for Medical-Surgical” (CIMEQ), May 14, 2009. Havana City, ”National Institute of Oncology and Radiobiology” (INOR), June 22, 2009. Havana City, “Enrique Cabrera” Hospital, October 17, 2008. Pinar del Río, “III Congreso Hospital”, August 10, 2008. Villa Clara, “Celestino Hernandez Robau” Hospital, July 28, 2008. Cienfuegos, “Gustavo Aldereguia Lima” Hospital, May 6, 2009. Camaguey, “Maria Curie” Hospital, October 13, 2008. Las Tunas, “Ernesto Guevara” Hospital, June 10, 2009. Holguin, “Vladimir Ilich Lenin” Hospital, August 25, 2008 Santiago de Cuba, “Conrado Benitez Hospital”, July 21, 2008. Granma, “Celia Sánchez Manduley” Hospital, June 5, 2009. Guantanamo, “Agostinho Neto” Hospital, May 14, 2010.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

06/01/2009

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

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)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

none

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

5 treatment schemes with Nimotuzumab

Phase:

4

Target sample size:

Inclusion of 3 years.

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Patricia MD.

Last Name:

Piedra

Affiliation:

CIMAB SA.

Postal Address:

206 No.1926 e/ 19 and 21 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Etx.111

Email :

patrip@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Patricia MD.

Last Name:

Piedra

Affiliation:

CIMAB SA.

Postal Address:

206 No.1926 e/ 19 and 21 Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

(537)271-50-57 Ext.111

Email :

patrip@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000089

Date of Registration in Primary Registry:

2009-10-22

Record Verification Date:

2012-01-10 19:00

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Nimotuzumab- Head and neck cancer

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