Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer

Sponsor
Per Pfeiffer
Study ID
NCT01020864
Phase
PHASE2
Status
Withdrawn

Conditions

  • Head and Neck Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    Cetuximab 500 mg/m² i.v. day 1, every 2nd week
  • Carboplatin — DRUG
    Carboplatin AUC = 3 i.v. day 1, every 21nd week
  • Vinorelbine — DRUG
    Vinorelbine 25 mg/m² i.v. day 1, every 2nd week

Study Details

This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.

Key Dates

Start date
Jan 31, 2010
Status verified
Oct 2020
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy
    Patients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week. Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment.

Primary Outcome Measure

Progression-free survival [ Time Frame: 2.5 years ]

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