Back to results

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

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 2

Locations

Slovenia

Study Type

Interventional

Intervention

docetaxel, cisplatin, 5-fluorouracil

radiotherapy

cetuximab, cisplatin

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, inoperable, induction chemotherapy, concomitant radiochemotherapy, biological agent, efficacy, toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Active, uncontrolled infection
Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT

Sites / Locations

Institute of Oncology Ljubljana

Outcomes

Primary Outcome Measures

locoregional control

Secondary Outcome Measures

feasibility (toxicity profile) of the proposed regimen

complete response rate

disease free survival

overall survival

late toxicity including thyroid function

Full Information

NCT ID

NCT00868491

First Posted

March 24, 2009

Last Updated

October 23, 2011

Sponsor

Institute of Oncology Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT00868491

Brief Title

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

Official Title

Induction Chemotherapy Followed by Chemoradiation With Cetuximab and Cisplatin for Inoperable Squamous Cell Carcinoma of the Head and Neck

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Oncology Ljubljana

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The treatment results with radiotherapy in inoperable squamous cell carcinoma of the head and neck are poor. In this proposed single-institution non-randomized, one-arm, open label phase II study, the authors will test 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. Chemotherapy doses will be as follows: 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 followed by 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. Three-dimensional conformal radiotherapy planning and delivery (35x2 Gy/day over 7 weeks {weeks 14 - 20}) will be used. The planned number of patients to be included is 30 and anticipated enrolment period is 12 months. The primary objective of the study is to determine locoregional control at 2 years post-therapy, whereas secondary objectives are to determine feasibility (toxicity profile) of the proposed regimen, to determine complete response rate after induction ChT as well as 14-16 weeks after the therapy, completion of ChRT to determine disease free survival at 2 years, overall survival at 2 years and late toxicity including thyroid function. Given the preliminary nature of the study, no stopping rule is prospectively planned outside of observed toxicity, which will be assessed and graded according to Common Terminology Criteria for Adverse Events version 3.0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel, cisplatin, 5-fluorouracil

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cetuximab, cisplatin

Other Intervention Name(s)

Erbitux

Intervention Description

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)

Primary Outcome Measure Information:

Title

locoregional control

Time Frame

at 2 years post-therapy

Secondary Outcome Measure Information:

Title

feasibility (toxicity profile) of the proposed regimen

Time Frame

during therapy

Title

complete response rate

Time Frame

after induction ChT and 14-16 weeks after the therapy

Title

disease free survival

Time Frame

at 2 years post-therapy

Title

overall survival

Time Frame

at 2 years post-therapy

Title

late toxicity including thyroid function

Time Frame

up to 2 years post-therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Active, uncontrolled infection Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Primož Strojan, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Oncology Ljubljana

City

Ljubljana

ZIP/Postal Code

SI-1000

Country

Slovenia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs