Clinical trial NCT00254137: Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: capecitabine
irinotecan
cetuximab
oxaliplatin
colorectal cancer
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Sanofi
name: Pfizer
name: Hoffmann-La Roche
First posted: 2005-11-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (CR+PR)
Secondary outcomes:
measure: Time to progression.
measure: Disease control rate (CR+PR+SD).
measure: Safety profile.
measure: Grade 3/4- toxicities.
Other outcomes:
Locations:
Study officials:
affiliation: University of Munich - Klinikum Grosshadern
name: Volker Heinemann, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: