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

Laryngeal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00941135
• Other study ID #: HN2008
• Secondary ID: EudraCT number:
• Status: Terminated
• Phase: Phase 2
• First received: July 15, 2009
• Last updated: September 28, 2011
• Start date: May 2009
• Est. completion date: May 2013

Study information

• Verified date: September 2011
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngeal Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Carlos Haya	Malaga	Andalucía
Spain	Clinica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital de Navarra	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion Miguel Servet	Salutis Research, SL, Unidad de Genética Clínica (Clínica Universitaria de Navarra)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No