Nimotuzumab in tumors of head and neck .Phase IV

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:

Safety and effectiveness of the nimotuzumab in tumors of head and neck in advanced stages, again diagnosis or recurrent.

Secondary indentifying numbers:

M9/CIMAB/AEC-4

Issuing authority of the secondary identifying numbers:

Center of Molecular Inmunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Ministry of Health publishes (MINSAP)

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 :

06/11/2012

Reference number:

24.154.12.B

Principal investigator

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

First name:

Rodolfo Arozarena Fundora.MD.Specialist in Otolaryngology Pedro Venereo Fundora.MD.Specialist in Otolaryngology

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 [1]

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:

Pinar del Río, III Congress,Nancy Díaz Castillo.MD.Specialist in oncology.Radiotherapy Cienfuegos,Gustavo Aldereguía Lima,Luis Alfonso Varona Vázquez.MD.Specialist in Oncology Sancti Spiritus ,Camilo Cienfuegos ,Jorge L.Arteaga Gattorno.MD.Specialist in Otolaryngology Ciego de Avila,Antonio Luaces ,Pedro V.Valladares Oliva.MD.Specialist in Oncology Camaguey,María Curie ,Lisandro Vila Martínez.MD.Specialist in Otolaryngology Holguín,Vladimir Ilich Lenin ,María de los Angeles Reynaldo González.MD.Specialist in Otolaryngology Bayamo-Granma ,Carlos M.de Céspedes ,María del Carmen Olivera Rodríguez.MD.Specialist in Oncology Manzanillo-Granma ,Celia Sánchez Manduley,Gustavo E.Pich Martí.MD.Specialist in Oncology Santiago de Cuba,Juan Bruno Zayas,Justo Despaigne Delisle.MD.Specialist in Oncology

Research ethics committees:

Camilo Cienfuegos ,august 27,2012. Vladimir Ilich Lenin ,september 21,2012. María Curie, september 25,2012. Juan Bruno Zayas,september 26,2012. III Congress,september 27,2012. Gustavo Aldereguía Lima,september 28,2012. Antonio Luaces ,october 2,2012. Hermanos Ameijeiras,october 4,2012. Carlos M.de Céspedes ,october 5,2012. Celia Sánchez Manduley,october 25,2012.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

26/11/2012

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:

Tumors of head and neck in advanced stages.

Intervention(s):

nimotuzumab, radiotherapy (RT), chemotherapy(QT) Treatment schemes: A NimoRT (RT + nimotuzumab) B NimoRT-QT (RT-QT + nimotuzumab) C Nimo-QT (QT + nimotuzumab) D Nimo (nimotuzumab) nimotuzumab: Ambulatory treatment:iv infusion(30 minutes, diluted in 250 ml of 0.9% NaCl) induction period:200 mg 1 time a week for 6 weeks. maintenance period:200 mg every 15 days to complete 2 years of treatment. radiotherapy (RT): Dosage:oscillate between 50.4 and 77 Gy Frequency:will be used cobalt 60 or linear accelerator ,fractional at 2 Gy/daily, days 1-5 of the week (Monday to Friday), from the 1st-5th or 8th week maximum where as the maximum dose to radiate (between 5 and 8 weeks), completing the amount indicated in no more 39 sessions. chemotherapy(QT): Route of administration:continuous iv infusion 1st option scheme every 21 days CDDP 75-100 mg/m2 2nd option weekly scheme during the RT CDDP 40 mg/m2 3rd option sequential scheme (QT 2 cycles - QT+RT or surgery-QT) CDDP- 75-100 mg/m2 + 5-FU 750-1000 mg/m2 2 cycles every 21 days, and evaluate whether continued treatment with surgery or RT, treatment that could be associated with CDDP weekly or every 21 days. Other options: MTX 40 mg/m2 weekly Triplet: CDDP, 5-FU and docetaxel every 28 days CDDP 75-100 mg/m2 + 5-FU 750-1000 mg/m2 + docetaxel 75 mg/m2, every 28 days(4 weeks) and by 4 cycles (weeks 2, 6,10 and 14).

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):

Serious EA with causal relationship with nimotuzumab (definitive, very likely or probable).Measuring time:24 months

Key secondary outcomes:

.Type of adverse event(event).Measuring time:24 months .Time between the moment of administration and the appearance of the EA(hours and minutes or days).Measuring time:24 months .Duration of the EA (days or hours and minutes).Measuring time:24 months .Seriousness of the EA (serious or not serious).Measuring time:24 months .Intensity of the EA(grade 1 Mild, grade 2 Moderate , grade 3 Severe, grade 4 Life -threatening or disabling , grade 5 Death).Measuring time:24 months .Causality Relationship(unknown, not related, possible, likely, very likely, and definitive).Measuring time:24 months .Attitude followed before the appearance of the EA(none, reduction of the dosage, temporary interruption of treatment, discontinuation of treatment).Measuring time:24 months .Treatment of the EA(indicated treatment to counteract the EA).Measuring time:24 months .Result of the EA(reversible effect, irreversible effect, death or loss of the follow-up of the patient).Measuring time:24 months .Lot of the nimotuzumab (the lot number of the used bulb for each administration the lot number of the used bulb for each administration).Measuring time:24 months .Clinical laboratory examinations(normal, out of the normal range not significant and out of significant normal range).Measuring time:previous inclusion,every 28 days in case of diagrams A Nimo RT and D Nimo, and schemas B Nimo RT-QT and C Nimo-QT before each cycle of QT and at the conclusion of the QT every 28 days .Overall survival(time in days or months elapsed since the inclusion of the patient in the study until his death or date in which are recorded in the HC the latest news from the patient).Measuring time:24 months .Quality of life(from the EORTC life quality questionnaires).Measuring time:at the time of inclusion and a semi-annual frequency during the 24 months of treatment .Progression-free survival( time in days or months elapsed from the moment that gets a response in the patient until it is objectively documented progressive disease or death).Measuring time:24 months .Objective response(complete response, partial , stabilization of the disease, progressive disease or death).Measuring time: every three months for 24 months

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:

N/A (No limit)

Inclusion criteria:

1.Patient that expresses the voluntary written into the studio with the signing of the informed consent. 2.Patient with age equal or greater than 18 years. 3.Expectation of life equal to or greater than 6 months. 4.Clinical status according to criteria of the ECOG less than or equal to 3. 5.Laboratory parameters(considering type of processing and equipment used): Hematopoietic - hemoglobin (Hb) greater than or equal to 100g/L hematocrit 0.30-0.40 in women and 0.30-0.44 in men, count of leukocytes ? 3000/?L = 3 x 109 L, CAN ? 1500/?L = 1.5 x 109 /L, platelets count greater than or equal to 100000/?L = 100 x 109 L, biochemical-liver: ALAT (TGP), ASAT (TGO), alkaline phosphatase, up to 2.5 times upper limit of normal for each clinical site; LDH and albumin normal value; Kidney: serum creatinine normal value.

Exclusion criteria:

1.Pregnancy, postpartum or breastfeeding. 2.Chronic disease associated in stage of decompensation (example: heart disease, diabetes mellitus, arterial hypertension). 3.Brain metastasis, diagnosed by TAC, not controlled or in progression. 4.Presence of a second primary tumor, with the exception of basal carcinomasor squamous skin and carcinoma in situ treated neck. 5.Patient who is receiving another investigational medicinal product at the time of inclusion. 6.Treatment with nimotuzumab in the 6 months prior to the time of inclusion. 7.Prior knowledge of allergy or sensitivity to the nimotuzumab or any component of the formulation.

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:

4 treatment schemes

Phase:

Target sample size:

404

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

Last Name:

Piedra Sierra,MD.

Affiliation:

Center of Molecular Immunology (CIM), CIMAB SA.

Postal Address:

206 Street No.1926 e/ 19 y 21,Atabey ,Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

053-7-271 50 57 Ext.111

Email :

patrip@cim.sld.cu [2]

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

Last Name:

Piedra Sierra,MD.

Affiliation:

Center of Molecular Immunology (CIM), CIMAB SA.

Postal Address:

206 Street No.1926 e/ 19 y 21, Atabey ,Playa.

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

053-7-271 50 57 Ext.111

Email :

patrip@cim.sld.cu [2]

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:

RPCEC00000145

Date of Registration in Primary Registry:

2013-02-01

Record Verification Date:

2013-01-09 19:00

Link to the spanish version:

Click here [3]