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

This study has been terminated.
Sponsor:
Collaborators:
Salutis Research, SL
Unidad de Genética Clínica (Clínica Universitaria de Navarra)
Information provided by (Responsible Party):
Fundacion Miguel Servet
ClinicalTrials.gov Identifier:
NCT00941135
First received: July 15, 2009
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Laryngeal Neoplasms
Other: Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Fundacion Miguel Servet:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

    Other Name: TPF (Chemotherapy Regimen code)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941135

Locations
Spain
Hospital Carlos Haya
Malaga, Andalucía, Spain, 29010
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Fundación Jiménez Díaz
Madrid, Spain, 28040
Sponsors and Collaborators
Fundacion Miguel Servet
Salutis Research, SL
Unidad de Genética Clínica (Clínica Universitaria de Navarra)
Investigators
Principal Investigator: Fernando Arias, MD Hospital de Navarra
Principal Investigator: Ruth Vera, MD Hospital de Navarra
  More Information

No publications provided

Responsible Party: Fundacion Miguel Servet
ClinicalTrials.gov Identifier: NCT00941135     History of Changes
Other Study ID Numbers: HN2008, EudraCT number: 2008-003365-29
Study First Received: July 15, 2009
Last Updated: September 28, 2011
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Laryngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Docetaxel
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014