Pharmacokinetics and Metabolic Activation of Capecitabine

Arbeitsgemeinschaft medikamentoese Tumortherapie

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Other: blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT01579357

AGMT-Capecet_PK

Details and patient eligibility

About

The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria selected:

• signed written informed consent
• male or female > 18 years
• K-ras wild type adenocarcinoma of the colon or rectum
• metastatic colorectal carcinoma
• ECOG <= 2

Exclusion Criteria selected:

• brain metastasis
• previous chemotherapy
• stage 3 or 4 heart failure
• uncontrolled angina
• pregnancy or lactation

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

A

Other group

Description:

Capecitabine in week 1,2,4,5,7 and 8 Cetuximab in week 3 to 9 Oxaliplatin in week 7

Treatment:

Other: blood samples

B

Other group

Description:

Capecitabine in weeks 1,2,4,5,7, and 8 Cetuximab in weeks 1,8 and 9 Oxaliplatin in week 7

Treatment:

Other: blood samples