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

July 15, 2009
September 28, 2011
May 2009
May 2013   (final data collection date for primary outcome 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941135 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Laryngeal Neoplasms
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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00941135
HN2008, EudraCT number: 2008-003365-29
No
Fundacion Miguel Servet
Fundacion Miguel Servet
  • Salutis Research, SL
  • Unidad de Genética Clínica (Clínica Universitaria de Navarra)
Principal Investigator: Fernando Arias, MD Hospital de Navarra
Principal Investigator: Ruth Vera, MD Hospital de Navarra
Fundacion Miguel Servet
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP