Clinical trial NCT01247337: Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocarcinoma
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: 6 months after last patient included
Secondary outcomes:
measure: Response rate.
timeFrame: 6 months after last patient included
measure: Survival
timeFrame: 6 months after last patient included
measure: Toxicity
timeFrame: 28 days after last treatment of last patient
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Department og Gastroenterology
name: Magnus Bergenfeldt, Consultan
role: PRINCIPAL_INVESTIGATOR
References: