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

Sponsor
Dorte Nielsen (Other)
Overall Status
Completed
CT.gov ID
NCT01247337
Collaborator
(none)
56
Enrollment
1
Location
1
Arm
60.5
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
  • Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
 Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 2, 2011
Actual Primary Completion Date :
Feb 18, 2016
Actual Study Completion Date :
Feb 18, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm chemotherapy treatment

Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
Intrahepatic oxaliplatin

Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
Oxaliplatin given intravenous

Outcome Measures

Primary Outcome Measures

  1. PFS [6 months after last patient included]

    Time from treatment start to progression or death.

Secondary Outcome Measures

  1. Response rate. [6 months after last patient included]

  2. Survival [6 months after last patient included]

  3. Toxicity [28 days after last treatment of last patient]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herlev Hospital Herlev Denmark 2730

Sponsors and Collaborators

  • Dorte Nielsen

Investigators

  • Principal Investigator: Magnus Bergenfeldt, Consultan, Department og Gastroenterology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Nov 24, 2010
Last Update Posted:
Oct 5, 2020
Last Verified:
Oct 1, 2020
Additional relevant MeSH terms:
Cholangiocarcinoma
Gemcitabine
Capecitabine
Oxaliplatin
Cetuximab

Study Results

No Results Posted as of Oct 5, 2020