Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
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ClinicalTrials.gov Identifier: NCT01247337 |
Recruitment Status :
Completed
First Posted : November 24, 2010
Last Update Posted : October 5, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholangiocarcinoma | Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | February 2, 2011 |
Actual Primary Completion Date : | February 18, 2016 |
Actual Study Completion Date : | February 18, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Single arm chemotherapy treatment |
Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
Intrahepatic oxaliplatin Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab Oxaliplatin given intravenous |
- PFS [ Time Frame: 6 months after last patient included ]Time from treatment start to progression or death.
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247337
Denmark | |
Herlev Hospital | |
Herlev, Denmark, 2730 |
Principal Investigator: | Magnus Bergenfeldt, Consultan | Department og Gastroenterology |
Responsible Party: | Dorte Nielsen, Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital., Herlev Hospital |
ClinicalTrials.gov Identifier: | NCT01247337 |
Other Study ID Numbers: |
GI 1003 |
First Posted: | November 24, 2010 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | October 2020 |
Cholangiocarcinoma Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Gemcitabine Capecitabine Oxaliplatin Cetuximab Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |