Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma
This study is currently recruiting participants.
Verified September 2012 by Herlev Hospital
Sponsor:
Herlev Hospital
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01247337
First received: November 23, 2010
Last updated: September 27, 2012
Last verified: September 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cholangiocarcinoma |
Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Drug Information available for:
Oxaliplatin
Gemcitabine
Gemcitabine hydrochloride
Capecitabine
Cetuximab
U.S. FDA Resources
Further study details as provided by Herlev Hospital:
Primary Outcome Measures:
- PFS [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]Time from treatment start to progression or death.
Secondary Outcome Measures:
- Response rate. [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 28 days after last treatment of last patient ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single arm chemotherapy treatment |
Drug: Oxaliplatin, capecitabine, gemcitabine, cetuximab
Intrahepatic oxaliplatin
Drug: Oxaliplatin, capecitabine, gemcitabine cetuximab
Oxaliplatin given intravenous
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247337
Contacts
| Contact: Dorte Nielsen, Professor | +4538682344 | dornie01@heh.regionh.dk |
| Contact: Birgitte Krogh Jensen, Study Nurse | +45 38689562 | bikrje01@heh.regionh.dk |
Locations
| Denmark | |
| Herlev Hospital | Recruiting |
| Herlev, Denmark, 2730 | |
| Contact: Dorte Nielsen, Professor +45 38682344 dornie01@heh.regionh.dk | |
| Contact: Birgitte Krogh Jensen, Studynurse +45 3868 9562 bikrje01@heh.regionh.dk | |
| Sub-Investigator: Benny Vittrup Jensen, Consultant | |
Sponsors and Collaborators
Herlev Hospital
Investigators
| Principal Investigator: | Magnus Bergenfeldt, Consultan | Department og Gastroenterology |
More Information
No publications provided
| Responsible Party: | Dorte Nielsen, Professor DMSci, Department of Oncology Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT01247337 History of Changes |
| Other Study ID Numbers: | GI 1003 |
| Study First Received: | November 23, 2010 |
| Last Updated: | September 27, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Cholangiocarcinoma Neoplastic Processes Neoplasms Pathologic Processes Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Gemcitabine Capecitabine Fluorouracil Oxaliplatin Cetuximab |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013