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

Fundacion Miguel Servet

Status and phase

Terminated

Phase 2

Conditions

Laryngeal Neoplasms

Treatments

Other: Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00941135

EudraCT number: 2008-003365-29

HN2008

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.