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Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Head and Neck Neoplasms

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Trial Information

Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer


Inclusion Criteria:



- Histologically verified squamous cell carcinoma of the head and neck where curatively
intended local treatment is not possible.

- Measurable or non-measurable disease.

- Disease progression during or after first line palliative chemotherapy with
cisplatinum or patients with recurrence < 6 months after primary concomitant
chemo-radiotherapy with cisplatinum.

- WHO Performance Status 0-2.

- Age ≥ 18 years.

- Neutrophil count (ANC) ≥ 1.5 x 10^9/l and platelets ≥ 100 x 10^9/l.

- Normal liver function with bilirubin < 1.5 x UNL (Upper Normal Limit), no UNL for
ALAT with liver metastases.

- Creatinin clearance ≥ 50 ml/min.

- Signed informed consent.

Exclusion Criteria:

- Other active malignant disease.

- Patients who are considered unable to follow the treatment plan or follow-up visits.

- Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1
year, active infection).

- Any condition or treatment which after the opinion of the investigator may expose the
patient to a risk or may influence the purpose of the trial.

- Pregnant or lactating women.

- Known hypersensitivity towards one or more of the components of the treatment.

- Prior treatment with either cetuximab or other inhibitors of EGFR.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

2.5 years

Safety Issue:

Yes

Principal Investigator

Per Pfeiffer, Professor, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

09.08

NCT ID:

NCT01020864

Start Date:

January 2010

Completion Date:

December 2012

Related Keywords:

  • Head and Neck Neoplasms
  • Platinum-resistent head and neck cancer
  • Cetuximab
  • Carboplatin
  • Navelbine
  • Phase II trial
  • Combination chemotherapy
  • Neoplasms
  • Head and Neck Neoplasms

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