EUCTR2004-001667-22-CZ
Active, not recruiting
Not Applicable
Cetuximab (Erbitux) in combination with cisplatin or carboplatin and 5-fluorouracil in the first line treatment of subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck - EXTREME
ConditionsRecurrent and/or metastatic Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 7.0Level: LLTClassification code 10025960
DrugsErbitux
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrent and/or metastatic Squamous cell carcinoma of the head and neck (SCCHN)
- Sponsor
- Merck KGaA
- Enrollment
- 420
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\=18 years of age
- •Histologically or cytologically confirmed diagnosis of SCCHN
- •Recurrent and/or metastatic SCCHN, not suitable for local therapy
- •At least 1 bi\-dimensionaly measurable lesion either by CT scan or MRI
- •Signed written informed consent before any study related activities are carried out
- •Tumor tissue available for immunohistochemical evaluation of EGFR expression
- •KPS of \=70 at study entry
- •Effective contraception for both male and female subjects if risk of conception exists
- •Neutrophils \=1500/mm³, platelet count \=100000/mm³, and hemoglobin \=9 g/dL
- •Total bilirubin \=2 × upper limit of normality (ULN); aspartate\-aminotransferase (AST) and alanine\-aminotransferase (ALT) \=3 × ULN
Exclusion Criteria
- •Prior systemic chemotherapy, except if given as part of a multimodal treatment for
- •locally advanced disease which was completed more than 6 months prior to study entry
- •Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
- •Nasopharyngeal carcinoma
- •Active infection (infection requiring IV antibiotics), including active tuberculosis, and
- •known and declared HIV.
- •Uncontrolled hypertension defined as systolic blood pressure \=180 mmHg and/or
- •diastolic blood pressure \=130 mmHg under resting conditions
- •Pregnancy (absence confirmed by serum ß\-HCG test) or lactation period
- •Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy
Outcomes
Primary Outcomes
Not specified
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