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Clinical Trials/EUCTR2004-001667-22-SE
EUCTR2004-001667-22-SE
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

Merck KGaA0 sites420 target enrollmentSeptember 17, 2004
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ConditionsMedDRA version: 7.0Level: LLTClassification code 10025960Recurrent and/or metastatic Squamous cell carcinoma of the head and neck (SCCHN)
DrugsErbitux

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
MedDRA version: 7.0Level: LLTClassification code 10025960
Sponsor
Merck KGaA
Enrollment
420
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 17, 2004
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Merck KGaA

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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