Therapy in combination with capecitabine, cetuximab and oxaliplati

• Conditions: This study is designed as a multicentre, parallel group phase II trial with 24 first-line patients with metastatic K-ras wild type CRC. The objective of this pharmacokinetic study is to exclude a probable influence of CETUX on the plasma disposition and metabolic activation of CCB and when this regimen is given combined with OxPt.; MedDRA version: 14.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002921-23-AT
• Lead Sponsor: Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-20
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Signed written informed consent,
Male or female = 18 years of age,
Diagnosis of histologically confirmed, K-ras wild-type” adenocarcinoma of the colon or rectum,
Metastatic colorectal carcinoma,
Karnofsky performance status of > 80 at study entry,
Eligible for therapy with Cetuximab plus Oxaliplatin and/or Capecitabine
Leucocytes = 3.0 x 10e9/L and neutrophils = 1.5 x 10e9/L, platelets = 100 x 10e9/L, and hemoglobin = 8 g/dL,
Bilirubin = 1.5 x ULN,
ASAT and ALAT = 2.5 x ULN (= 5 x ULN if liver metastasis are present),
Serum creatinine = 1.5 x ULN.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Brain metastasis (known or suspected)
Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is > 6 months,
Stage 3 or 4 heart failure defined according to the NYHA criteria,
Uncontrolled angina,
Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol,
Administration of any investigational agent(s) within 4 weeks prior to entry,
Previous exposure to EGFR-pathway targeting therapy,
Known grade 3 or 4 allergic reaction to any of the components of the treatment,
Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the trial),
Pregnancy or lactation,
Inadequate contraception (male or female patients) if of childbearing or procreational potential,
Known drug abuse/ alcohol abuse,
Legal incapacity or limited legal capacity,
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: investigation of a possible modulation of co-administered CETUX on the metabolic activation of CCB, when administered concomitantly with OxPt;Primary end point(s): A metabolic activation of CCB modulated by co-administered CETUX is to be expected <br><br>;Timepoint(s) of evaluation of this end point: End of the study approximately (03/2013);Main Objective: investigation of a possible modulation of co-administered CETUX on the metabolic activation of CCB

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): CCB is administered concomitantly with OxPt. The influence of a metabolic activation of CCB by co-administered CETUX can be excluded in this regimen.;Timepoint(s) of evaluation of this end point: End of the study approximately (03/2013)