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Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer

Information source: Technische Universitšt Dresden
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Colorectal Cancer

Intervention: Cetuximab (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Technische Universitšt Dresden

Official(s) and/or principal investigator(s):
Gunnar Folprecht, Dr., Principal Investigator, Affiliation: University Hospital Dresden, Medical Department I

Summary

The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil (5-FU)/folinic acid (FA) as first-line treatment for metastatic colorectal cancer.

Clinical Details

Official title: 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

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

Primary outcome: 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

Secondary outcome: To assess the treatment regarding the following: feasibility, toxicity, response rate, resection rate, progression free and overall survival

Detailed description: 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 planned. Expanded cohort: The MTD cohort will be expanded to a total of 16 patients.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

- ‚Č• 18 years of age

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

exists

- Adequate bone marrow function: neutrophil blood cell count (NBC) ‚Č• 1. 5 x 10^9/L,

platelet count ‚Č• 100 x 10^9/L, hemoglobin ‚Č• 5. 96 mmol/L (10 g/dL)

- Adequate liver and renal function: bilirubin ‚ȧ 1. 5 x upper normal level (UNL) and not

increasing more than 25% within the last 4 weeks; ASAT and ALAT ‚ȧ 5 x UNL; serum creatinine ‚ȧ 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

inclusion.

- 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

Locations and Contacts

Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Essen 45112, Germany

Universitaetsklinik Mannheim GmbH, III. Medizinische Klinik, Mannheim 68167, Germany

Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik, Dresden, Sachsen 01307, Germany

Additional Information

Starting date: January 2007
Last updated: February 26, 2009

Page last updated: August 20, 2015

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