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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

Sponsor
Fundacion Miguel Servet (Other)
Overall Status
Terminated
CT.gov ID
NCT00941135
Collaborator
Salutis Research, SL (Other), Unidad de Genética Clínica (Clínica Universitaria de Navarra) (Other)
70
Enrollment
4
Locations
48
Duration (Months)
17.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Docetaxel+Cisplatin+5-FU+ Radiotherapy+Cetuximab
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
May 1, 2009
Anticipated Primary Completion Date :
May 1, 2013
Anticipated Study Completion Date :
May 1, 2013

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hospital Carlos Haya Malaga Andalucía Spain 29010
2 Clinica Universitaria de Navarra Pamplona Navarra Spain 31008
3 Hospital de Navarra Pamplona Navarra Spain 31008
4 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundacion Miguel Servet
ClinicalTrials.gov Identifier:
NCT00941135
Other Study ID Numbers:
  • HN2008
  • EudraCT number: 2008-003365-29
First Posted:
Jul 17, 2009
Last Update Posted:
Sep 29, 2011
Last Verified:
Sep 1, 2011
Additional relevant MeSH terms:
Laryngeal Neoplasms
Docetaxel
Cetuximab

Study Results

No Results Posted as of Sep 29, 2011