Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

Metastatic Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254137
• Other study ID #: CRC-02-2004
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2005
• Last updated: October 27, 2010
• Start date: September 2004
• Est. completion date: November 2006

Study information

• Verified date: September 2004
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• capecitabine

• irinotecan

• oxaliplatin

• cetuximab

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Hoffmann-La Roche, Merck Sharp & Dohme Corp., Pfizer, Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (CR+PR)
Secondary	Time to progression.
Secondary	Disease control rate (CR+PR+SD).
Secondary	Safety profile.
Secondary	Grade 3/4- toxicities.