Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247337
• Other study ID #: GI 1003
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2011
• Est. completion date: February 18, 2016

Study information

• Verified date: October 2020
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 18, 2016
• Est. primary completion date: February 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Drug:
• Oxaliplatin, capecitabine, gemcitabine, cetuximab
Intrahepatic oxaliplatin
• Oxaliplatin, capecitabine, gemcitabine cetuximab
Oxaliplatin given intravenous

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Dorte Nielsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Time from treatment start to progression or death.	6 months after last patient included
Secondary	Response rate.		6 months after last patient included
Secondary	Survival		6 months after last patient included
Secondary	Toxicity		28 days after last treatment of last patient