Clinical trial NCT00941135: Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab
Official title: Phase II Study of TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab "Boost Concomitant" With Cetuximab in Patients With Local Advanced Larynx/Hypolarynx Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Laryngeal Neoplasms
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Salutis Research, SL
name: Unidad de Genética Clínica (Clínica Universitaria de Navarra)
First posted: 2009-07-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To evaluate progression-free time in patients with complete or partial response >30% evaluated over primary tumour(T and N) after TPF induction treated with RT + Cetuximab.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Hospital Carlos Haya
state: Andalucía
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
Study officials:
affiliation: Hospital de Navarra
name: Fernando Arias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Navarra
name: Ruth Vera, MD
role: PRINCIPAL_INVESTIGATOR
References: