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

NCT01247337 | Completed Phase 2 DMC

• 1 other identifier: GI 1003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Time from treatment start to progression or death.

  6 months after last patient included

Secondary Outcomes (3)

• Response rate.

  6 months after last patient included

• Survival

  6 months after last patient included

• Toxicity

  28 days after last treatment of last patient

Study Arms (1)

Single arm chemotherapy treatment

EXPERIMENTAL

Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab; Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab

Interventions

Oxaliplatin, capecitabine, gemcitabine cetuximab DRUG

Oxaliplatin given intravenous

Single arm chemotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dorte Nielsen: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Oxaliplatin; Capecitabine; Gemcitabine; Cetuximab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Magnus Bergenfeldt, Consultan

  Department og Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital.

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 24, 2010
• Study Start: February 2, 2011
• Primary Completion: February 18, 2016
• Study Completion: February 18, 2016
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

DK (1)