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Open Labeled, Multicenter Phase I/II Study Evaluating the Dose Escalation/Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan as First-Line Treatment of Metastatic Colorectal Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Metastatic Colorectal Cancer

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Trial Information

Open Labeled, Multicenter Phase I/II Study Evaluating the Dose Escalation/Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan as First-Line Treatment of Metastatic Colorectal Cancer

Dose escalation:

The first three patients will receive chemotherapy at the dose level 1 for 6 weeks (first
three cycles). The dose will be escalated for the next patients by one dose level if none of
the three patients at a dose level experience a dose-limiting toxicity (DLT) during the
first six weeks. If one of the three patients has a DLT, an additional three patients will
be enrolled at this dose level and the dose will be escalated if no additional patients
experience a DLT. Otherwise, the dose escalation will be stopped, and the last dose will be
regarded as the maximum tolerated dose (MTD). An intra-individual dose escalation is not

Expanded cohort:

The MTD cohort will be expanded to a total of 16 patients.

Inclusion Criteria:

- Diagnosis of non-resectable, histologically confirmed, epithelial growth factor
receptor(EGFR)-positive or negative colorectal cancer

- WHO Performance status 0 or 1

- Signed written informed consent

- ≥ 18 years of age

- Effective contraception for both male and female subjects if the risk of conception

- Adequate bone marrow function: neutrophil blood cell count (NBC) ≥ 1.5 x 10^9/L,
platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 5.96 mmol/L (10 g/dL)

- Adequate liver and renal function: bilirubin ≤ 1.5 x upper normal level (UNL) and not
increasing more than 25% within the last 4 weeks; ASAT and ALAT ≤ 5 x UNL; serum
creatinine ≤ 1.5 x UNL.

Exclusion Criteria:

- Previous exposure to epidermal growth factor receptor-targeting therapy

- Previous chemotherapy for colorectal cancer except for adjuvant treatment with
progression of disease documented > 6 months after end of adjuvant treatment or 5-FU
in combination with radiotherapy for rectal cancer

- Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before

- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy.

- Investigational agents or participation in clinical trials within 30 days before
start of the treatment in study.

- Clinically relevant coronary disease or myocardial infarction within 12 months before
study entry.

- Peripheral neuropathy > CTC (Common Toxicity Criteria)grade I

- Inflammatory bowel disease

- Previous malignancy (except for colorectal cancer, history of basal cell carcinoma of
skin or pre-invasive carcinoma of the cervix with adequate treatment)

- History of severe psychiatric illness

- Drug or alcohol abuse

- Known hypersensitivity reaction to any of the components of study treatment

- Pregnancy (absence to be confirmed by b-hCG (pregnancy-) test) or lactation period

- Brain metastasis and/or leptomeningeal disease (known or suspected)

- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

Type of Study:


Study Design:

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

Outcome Measure:

To assess a maximal tolerable dose and the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-FU/folinic acid as first-line treatment for metastatic colorectal cancer

Principal Investigator

Gunnar Folprecht, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Dresden, Medical Department I


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Metastatic Colorectal Cancer
  • phase I/II
  • cetuximab
  • oxaliplatin
  • irinotecan
  • 5-FU
  • chemotherapy
  • dose escalation
  • safety
  • Colorectal Neoplasms