Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer

NCT00868491 | Completed Phase 2 DMC

• 1 other identifier: EMR-62202-717
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and toxicity of docetaxel/cisplatin/5-fluorouracil induction chemotherapy (4 cycles) followed by concomitant chemoradiation with cetuximab and weekly cisplatin in patients with inoperable squamous cell carcinoma of the head and neck.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; inoperable; induction chemotherapy; concomitant radiochemotherapy; biological agent; efficacy; toxicity

Outcome Measures

Primary Outcomes (1)

• locoregional control

  at 2 years post-therapy

Secondary Outcomes (5)

• feasibility (toxicity profile) of the proposed regimen

  during therapy

• complete response rate

  after induction ChT and 14-16 weeks after the therapy

• disease free survival

  at 2 years post-therapy

• overall survival

  at 2 years post-therapy

• late toxicity including thyroid function

  up to 2 years post-therapy

Study Arms (1)

induction chemotherapy plus chemo-immuno-radiotherapy

EXPERIMENTAL

TPF induction chemotheraopy, radiotehrapy, concomitant cisplatin and cetuximab

Drug: docetaxel, cisplatin, 5-fluorouracil; Radiation: radiotherapy; Drug: cetuximab, cisplatin

Interventions

docetaxel, cisplatin, 5-fluorouracil DRUG

docetaxel 75 mg/m2 I.V. day 1, cisplatin 75 mg/m2 I.V. day 1, 5-fluorouracil 750 mg/m2 I.V. continuous infusion days 1-5 repeated every 21 days for 4 cycles

induction chemotherapy plus chemo-immuno-radiotherapy

radiotherapy RADIATION

Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks - weeks 14 - 20 of the study protocol

induction chemotherapy plus chemo-immuno-radiotherapy

cetuximab, cisplatin DRUG

* cetuximab 400 mg/m2 I.V. week 13, cetuximab 250 mg/m2 I.V. weeks 14-20 * cisplatin 30 mg/m2 I.V. weeks 14-20 (concomitantly with radiothrapy)

Also known as: Erbitux

induction chemotherapy plus chemo-immuno-radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Squamous cell carcinoma, histologically proven
• Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
• Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb) - - without distant metastases (M0-stage)
• Male or female ≥18 years of age
• Expected survival \>6 months
• Presence of at least one bidimensionally measurable index lesion
• Effective contraception for both male and female subjects if risk of conception exists
• WHO performance status 0-2
• Laboratory parameters:
• hemoglobin ≥100 g/L leukocyte count \> 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L platelet count \> 100x109/L total bilirubin \< 1.25x upper normal limit transaminases (ALT, AST) \< 5x upper normal limit creatinine clearance ≥ 55 mls/minute
• Signed written informed consent

You may not qualify if:

• Metastatic disease
• Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses
• ChT or XRT ineligibility:
• Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT; Clinically evident hearing impairment; Pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0;
• Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)
• Previous administration of EGFR pathway-targeting therapy
• Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol
• Participation in another clinical trial within 30 days prior to study entry
• Pregnancy or breast feeding
• History of severe acute pulmonary disease
• Any investigational agent within past 30 days
• Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal cell carcinoma of the skin or pre- invasive carcinoma of the cervix
• Known drug abuse / severe alcohol abuse
• Legal incapacity or limited legal capacity
• Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, SI-1000, Slovenia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin; Fluorouracil; Radiotherapy; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Primož Strojan, MD

  Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: October 30, 2011
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

SL (1)