Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab

NCT ID: NCT00941135

Last Updated: 2011-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-05-31

Brief Summary

To evaluate the progression free time in patients with completed or partial response > 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.

Conditions

Laryngeal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab

Docetaxel:75 mg/m2/d IV Cisplatin:75 mg/m2/d IV 5-FU:750 mg/m2/d IV TPF 3 cycles every 3 weeks

Radiotherapy: Total 72 Gy in 42 fractions Cetuximab: 250 mg/m2/d Days 1, 8, 15, 22, 29, 36 and 43

Intervention Type: OTHER

Other Intervention Names

TPF (Chemotherapy Regimen code)

Eligibility Criteria

Inclusion Criteria

• Patient informed consent must be signed before to start the study.
• Age between 18 to 70 years.
• Performance Status 0-1 according to ECOG scale at the moment of inclusion.
• Life expectancy >3 months.
• Confirmed anatomopathologic diagnosis of local advance scaly larynx or hypolarynx carcinoma III or IV stage without evidence of distance metastasis, which surgery involve a total laryngectomy.
• T3, T4A, T4B or T2 not candidate to a partial laryngectomy. In case of T2 of both locations it will be required III or IVA stage.
• Patients in medical conditions to receive neoadjuvant treatment with TPF followed by hyperfractionated radiotherapy combined with cetuximab.
• Presence of a injury measurable with RECIST criteria.
• Neutrophils > or = 1500/mm3, platelets > or = 150.000/mm3 and haemoglobin > or =10 g/dL.
• Renal Function appropriate
• Hepatic Function appropriate
• Serum Calcium tight to albumine < or = 1,25 x upper normal limit (UNL).
• Nutritional status appropriate: weight loss < 20% and albumine > or = 35 g/L.
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria

• Metastatic disease.
• Surgical treatment, radiotherapy and/or previous chemotherapy.
• Another tumour locations in head and neck area different from larynx or hypo larynx.
• Another stages different from III or IVa without distant metastasis and resectable disease.
• Another previous scaly carcinoma
• Diagnosis of another neoplasia in last 5 years, except cervix carcinoma in situ and/or basocellular cutaneous carcinoma adequately treated.
• Active infection treated by ATB IV, including active tuberculosis and VIH.
• Hypertension not controled defined as systolic > or = 180 mm Hg and/or diastolic > or =130 mm Hg at rest.
• Pregnant/lactating women.
• Systemic immune treatment, chronic and concomitant, or cancer hormone treatment.
• Another antineoplastics concomitant treatments.
• Coronary artery disease or history of heart attack in the last 12 months or high risk of arrythmia uncontrolled or cardiac insufficiency uncontrolled.
• EPOC that required more than 3 hospitalizations in the last 12 months.
• Active ulcus not controled.
• Psychiatric illness/social situations that would limit compliance with study requirements
• Drug abuse (except alcohol abuse)
• Knowledge of Allergic to study treatment.
• Previous treatment with Monoclonal antibodies.
• Any experimental treatment in the previous 30 days to start the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salutis Research, SL

UNKNOWN

Sponsor Role: collaborator

Unidad de Genética Clínica (Clínica Universitaria de Navarra)

UNKNOWN

Sponsor Role: collaborator

Fundacion Miguel Servet

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Arias, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Navarra

Ruth Vera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Navarra

Locations

Hospital Carlos Haya

Málaga, Andalusia, Spain

Fundación Jiménez Díaz

Madrid, Madrid, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital de Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

EudraCT number: 2008-003365-29

Identifier Type: -

Identifier Source: secondary_id

HN2008

Identifier Type: -

Identifier Source: org_study_id