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

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

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.

Study Overview

• Status: Terminated
• Conditions: Laryngeal Neoplasms
• Intervention / Treatment: Other: Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Andalucía
    • Malaga, Andalucía, Spain, 29010
      • Hospital Carlos Haya
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet
• Collaborators: Salutis Research, SL; Unidad de Genética Clínica (Clínica Universitaria de Navarra)
• Investigators: Principal Investigator: Fernando Arias, MD, Hospital de Navarra

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Estimate): September 29, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Laryngeal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Cetuximab
• Other Study ID Numbers: HN2008; EudraCT number: 2008-003365-29