NCT01830556

Brief Summary

Primary To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy. Secondary To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and neck the following study variables between both treatment arms:

  • Best overall response
  • Duration of response
  • Time to treatment failure
  • Overall survival
  • Safety

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Typical duration for phase_2

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

April 10, 2013

Last Update Submit

May 19, 2013

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy.

    3 years

Secondary Outcomes (1)

  • Best overall response

    3 years

Study Arms (2)

Arm A: cetuximab with 5FU and carboplatin or cisplatin

ACTIVE COMPARATOR

Arm A:Day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes Day 1 Cisplatin 100mg/m2 or Carboplatin AUC 5 day 1-4 5-Fluorouracil 1000 mg/m2 iv 24 h maintenance treatment thereafter with cetuximab 500 mg/m2 every second week until PD or toxicity

Drug: Cetuximab

Arm B: cetuximab paclitaxel and carboplatin

EXPERIMENTAL

Arm B day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes day 1 Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 treatment for 6 cycles thereafter maintenance treatment day 1 Cetuximab 500 mg/m2 every second week treatment until progress or unacceptable toxicity

Drug: Cetuximab

Interventions

CetuximabDRUG

Group A:Day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes Day 1 Cisplatin 100mg/m2 or Carboplatin AUC 5 day 1-4 5-Fluorouracil 1000 mg/m2 iv 24 h Group B day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes day 1 Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 treatment for 6 cycles thereafter day 1 Cetuximab 500 mg/m2 every second week treatment until progress or unacceptable toxicity

Also known as: Erbitux
Arm A: cetuximab with 5FU and carboplatin or cisplatinArm B: cetuximab paclitaxel and carboplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Histologically or cytologically confirmed SCCHN, relapsed and/or metastatic
  • Patient must have a life expectancy of at least 3 months allowing adequate follow-up toxicity evaluation.
  • Clinical examination
  • unidimensional lesion according to RECIST 1.1.
  • PS WHO 0-1 at study entry
  • Adequate hematological function defined as WBC ≥3 x 109/litre and platelets ≥100 x 109/litre, ANC \> 1.5 x 109/litre and Hb \> 100 g/L
  • Adequate liver function; bilirubin \< 1.5 x UNL, ALAT or ASAT\<3.0 UNL, alkaline phosphates \< 2.5 UNL.
  • Creatinine clearance \> 50mL/min
  • Written informed consent must be obtained according to the local Ethics committee.

You may not qualify if:

  • \> 75 years
  • Nasopharyngeal cancer and cancer of the paranasal sinuses
  • Inability to follow the treatment and evaluation schedule
  • Any other condition or therapy which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives
  • Pregnant or nursing females or male or female of child-bearing potential not using adequate methods of birth-control
  • Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
  • Known hypersensitivity to any of the components of the treatment
  • Legal incapacity
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Patients with clinically relevant neuropathy
  • Previously treated for relapsed or metastatic SCCHN except radiotherapy for previously treated relapse if terminated \> 3 months before start of treatment.
  • Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Lena Specht

Copenhagen, 2100, Denmark

RECRUITING

Karolinska Universityhospital

Stockholm, Stockholm County, 17176, Sweden

RECRUITING

Hedda Haugen

Gothenburg, 413 45, Sweden

RECRUITING

Karin Söderström

Umeå, 90189, Sweden

RECRUITING

Akademiska Universityhospital

Uppsala, 751 85, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Signe Friesland, MD Phd

    Karolinska Universityhospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

November 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2015

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

SE(4)DK(1)