Overview

This trial is active, not recruiting.

Condition cholangiocarcinoma
Treatments oxaliplatin, capecitabine, gemcitabine, cetuximab, oxaliplatin, capecitabine, gemcitabine cetuximab
Phase phase 2
Sponsor Dorte Nielsen
Start date November 2010
End date March 2014
Trial size 100 participants
Trial identifier NCT01247337, GI 1003

Summary

A phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic gemcitabine and capecitabine in combination with cetuximab in patient with non-resectable liver metastases from cholangiocarcinoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
oxaliplatin, capecitabine, gemcitabine, cetuximab
Intrahepatic oxaliplatin
oxaliplatin, capecitabine, gemcitabine cetuximab
Oxaliplatin given intravenous

Primary Outcomes

Measure
PFS
time frame: 6 months after last patient included

Secondary Outcomes

Measure
Response rate.
time frame: 6 months after last patient included
Survival
time frame: 6 months after last patient included
Toxicity
time frame: 28 days after last treatment of last patient

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:• Informed consent - Age > 18 years - Performance status 0-1; expected survival ≥ 3 months - Patient with histologically or cytologically adenocarcinoma developed from cells in the gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with above mentioned and radiologic findings consistent with cholangiocarcinoma - Liver metastases not suitable for surgery or other local treatment - Extrahepatic disease should be excluded by PET-CT-scan. - Prior treatment with chemotherapy or no progression on first line treatment - Metastases < 70 % of the liver - neutrophile granulocytes ≥ 1.5 x 109/l og thrombocytes ≥ 100 x 109/l - bilirubin < 2.0 x UNL (upper normal limit). - creatinine-clearance ≥ 30 ml/min. - INR < 2. - Intrahepatic treatment can be accomplished - The patients is approved by a multidisciplinary team Exclusion Criteria:• Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin. - Cytotoxic or experimental treatment within a 14 days period before start of trial medication - The patient is not allowed to participate in other clinical trials. - Any clinical symptoms suggesting peripheral neuropathy grade 2 - Other severe medical conditions - Severe cardial disease or AMI < 1 year - Presence of diseases preventing oral therapy - Patients with uncontrolled infection - Pregnant or lactating women - Women capable of childbearing not using a sufficient method of birth control - Patients not able to understand the treatment or to collaborate - Prior serious or unsuspected reaction after treatment with fluoropyrimidine - Known prior hypersensitivity reactions to the agents - Interstitial pneumonitis or pulmonary fibrosis

Additional Information

Official title Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Gemcitabine and Capecitabine in Combination With Cetuximab in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma. A Phase II Trial.
Principal investigator Magnus Bergenfeldt, Consultan
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Herlev Hospital.