Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN (HNO-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01884259
First received: May 18, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.


Condition Intervention Phase
Squamous Cell Carcinoma of the Hypopharynx Stage III
Squamous Cell Carcinoma of the Hypopharynx Stage IV
Squamous Cell Carcinoma of the Larynx Stage III
Squamous Cell Carcinoma of the Larynx Stage IV
Squamous Cell Carcinoma of the Oropharynx Stage III
Squamous Cell Carcinoma of the Oropharynx Stage IV
Squamous Cell Carcinoma of the Oral Cavity Stage III
Squamous Cell Carcinoma of the Oral Cavity Stage IV
Drug: Docetaxel
Drug: Cisplatin
Drug: 5-fluorouracil
Biological: Cetuximab Induction
Biological: Cetuximab Radioimmunotherapy
Radiation: Boost irradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • Response Rate (CR, PR) [ Time Frame: 3 months after end of therapy ] [ Designated as safety issue: No ]
    RECIST criteria


Secondary Outcome Measures:
  • Overall Response Rate (CR, PR, PD, SD) [ Time Frame: until 3 months after therapy ] [ Designated as safety issue: No ]
    RECIST

  • Locoregionally monitoring [ Time Frame: after one year ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: 1, 2 and 5 years after start of therapy ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: During treatment and until 60 months after end of radiotherapy ] [ Designated as safety issue: Yes ]

    Information about acute toxicity (grade, relation to study drug) during study treatment and until 3 months after end of radiotherapy will be collected for each patient using CTCAE 3.0 criteria list.

    Information about late toxicity (grade) will be collected after 3 months of radiotherapy and until 60 months after radiotherapy using RTOG/EORTC toxicity criteria.

    Kind and number of toxicities will be described according to grade. The highest grade of each patient and toxicity will be analysed.


  • Overall-Survival [ Time Frame: 1, 2 and 5 years after start of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A

Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Active comparator is 5-fluorouracil for first three cycles.

Drug: Docetaxel
75 mg/m² on day 1 of 21-days cycle
Drug: Cisplatin
75 mg/m² on day 1 of 21-days cycle
Drug: 5-fluorouracil
750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
Biological: Cetuximab Radioimmunotherapy
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
Other Name: Erbitux
Radiation: Boost irradiation
First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks
Other Name: Concomitant boost-irradiation
Experimental: B

All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Experimental: cetuximab for the first three cycles.

Drug: Docetaxel
75 mg/m² on day 1 of 21-days cycle
Drug: Cisplatin
75 mg/m² on day 1 of 21-days cycle
Biological: Cetuximab Induction
weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
Other Name: Erbitux
Biological: Cetuximab Radioimmunotherapy
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
Other Name: Erbitux
Radiation: Boost irradiation
First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks
Other Name: Concomitant boost-irradiation

Detailed Description:

It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV
  • One measureable lesion (CT oder MR)
  • Age 18 - 75 (including)
  • Performance Score ECOG 0 - 1

Exclusion Criteria selected:

  • Distant metastases
  • ECOG Score >1
  • Prior radiation (Head and neck area)
  • Creatinin Clearance below 60 ml/µl
  • Acute infections
  • Neuropathy grade 3 or 4
  • Myocardial Infarction within the last 12 months
  • Acute coronary syndrome or othe clinically significant cardiovascular diseases
  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: NCT01884259

Locations
Austria
Landeskrankenhaus Feldkirch Recruiting
Feldkirch, Austria, A-6807
Contact: Alexander DeVries, Prof.Dr.    +43 5522 303 ext 3300    alexander.devries@lkhf.at   
Principal Investigator: Alexander DeVries, Prof.Dr.         
Landesklinikum Krems Recruiting
Krems, Austria, A-3500
Contact: Gabi Schmoranzer    +43 6769101268    office@osteoprotect.at   
Contact: Elisabeth Zwickl-Traxler, MSc       office3@osteoprotect.at   
Principal Investigator: Martin Pecherstorfer, Prof.Dr.         
AKH Linz, Innere Medizin 3, Zentrum f. Haematologie u. med. Onkologie Recruiting
Linz, Austria, A-4021
Contact: Bettina Pfleger    +43 7327806 ext 6207    bettina.pfleger@akh.linz.at   
Contact: Elisabeth Morbitzer    +43 7327806 ext 6204    elisabeth.morbitzer@akh.linz.at   
Principal Investigator: Michael A. Fridrik, Univ.Doz.Dr         
Krankenhaus d. Barmherzigen Schwestern Linz Recruiting
Linz, Austria, A-4010
Contact: Magdalena Sturm, DI    +43 732 7677 ext 7521    magdalena.sturm@bhs.at   
Principal Investigator: Martin Burian, Prof.Dr.         
PMU Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Michaela Schachner, Mag.    +43 662 4482 ext 2847    m.schachner@salk.at   
Principal Investigator: Richard Greil, Prof. Dr.         
Hanusch Krankenhaus Wien Recruiting
Vienna, Austria, 1140
Contact: Felix Keil, Prof.Dr.       felix.keil@wgkk.at   
Contact: Eva Sallaberger, MSc       eva.sallaberger@wgkk.at   
Principal Investigator: Felix Keil, Prof.Dr.         
Universität f. Strahlentherape, AKH Wien Recruiting
Vienna, Austria, A-1090
Contact: Edgar Selzer, Prof.Dr.    +43 1 40400 ext 2650    edgar.selzer@meduniwien.ac.at   
Principal Investigator: Edgar Selzer, Prof.Dr.         
Klinikum Kreuzschwestern Wels GmbH Recruiting
Wels, Austria, A-4600
Contact: Ina Pühringer    +43 7242 415 ext 92185    ina.puehringer@klinikum-wegr.at   
Contact: Bettina Buchbauer       bettina.buchbauer@klinikum-wegr.at   
Principal Investigator: Beate Mayrbäurl, OA Dr.         
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Investigators
Principal Investigator: Felix Keil, Prof.Dr. Hanuschkrankenhaus
  More Information

Additional Information:
No publications provided

Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01884259     History of Changes
Other Study ID Numbers: AGMT_HNO 2
Study First Received: May 18, 2012
Last Updated: August 14, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
local advanced squamous cell carcinoma
Larynx
Hypopharynx
Oropharynx
Cavum oris
docetaxel
cisplatin
5-fluorouracil
Cetuximab

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Laryngeal Diseases
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Stomatognathic Diseases
Cetuximab
Cisplatin
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 19, 2014