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A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.


Phase 2
18 Years
75 Years
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.


Inclusion Criteria:



- Histologically confirmed metastatic colorectal cancer.

- EGF-receptor testing.

- No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an
interval ³ 6 months).

- No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against
the EGF-pathway.

- No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start
of study treatment.

- Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).

- Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy
³ 3 months. Effective contraception if risk of conception exists.

- Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils
³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and
ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).

- Written informed consent.

Exclusion Criteria:

- Concurrent treatment of colorectal cancer (except study medication).

- EGF-receptor testing not possible.

- Known DPD-deficiency (no particular screening necessary). Known
Gilbert-Meulengracht-Syndrome (no particular screening necessary).

- Known or expected contraindication against study medication.

- Participation in other studies during 30 days before study entry.

- Prior myocardial infarction, severe renal insufficiency (creatinine clearance
£30ml/min).

- Previous malignancy (except colorectal cancer, history of basal cell carcinoma of
skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of
disease during 5 years).

- Known or suspected cerebral metastasis.

- History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.

- Drug or alcohol abuse. Lack of adequate legal capacity.

- Breast-feeding or pregnant women.

- Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or
derivatives.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate (CR+PR)

Principal Investigator

Volker Heinemann, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Munich - Klinikum Grosshadern

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CRC-02-2004

NCT ID:

NCT00254137

Start Date:

September 2004

Completion Date:

November 2006

Related Keywords:

  • Metastatic Colorectal Cancer
  • capecitabine
  • irinotecan
  • cetuximab
  • oxaliplatin
  • colorectal cancer
  • Colorectal Neoplasms

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