Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma - Full Text View

Sponsored by:	Vejle Hospital
Information provided by:	Vejle Hospital
ClinicalTrials.gov Identifier:	NCT00779454

Purpose

The purpose of this study is partly to continue the good experience the investigators have with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding a biological antibody to the treatment of patients with wild-type KRAS.

Condition	Intervention	Phase
Cholangiocarcinoma	Drug: Gemcitabine, Oxaliplatin, Capecitabine, Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine	Phase II

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Capecitabine Oxaliplatin Panitumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Safety/Efficacy Study
Official Title:	Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:

Progression free survival

Secondary Outcome Measures:

Response rate
Toxicity
Overall survival

Estimated Enrollment:	58
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
wt-KRAS	Drug: Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
mut-KRAS	Drug: Gemcitabine, Oxaliplatin, Capecitabine,

Detailed Description:

Cholangiocarcinoma is a relatively rare disease. In Denmark approx. 150 patients are diagnosed each year. A small part of the patients can be offered surgery, but the operation will rarely be radical, and most patients with cholangiocarcinoma are therefore candidates for chemotherapy.

In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been used in recent years. Based on experience with gastrointestinal tumors, however, there seems to be an effect of new biological substances, including EGFR antibodies. There are casuistic reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.

The effect of EGF is mediated through an intracellular pathway involving the KRAS protein. It has been shown that a mutation of KRAS causes the EGF system to be constantly activated. Effect in patients with a KRAS mutation is therefore not to be expected. Approx. 50% of the patients present this mutation.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically verified adenocarcinoma arisen from gallbladder, extra or intrahepatic bile ducts or malignant cells consistent with the above and concomitant radiologic findings consistent with cholangiocarcinoma.
Curative treatment presently discounted (surgery, stereotactic radiotherapy, etc.).
KRAS analyzed and found wild-type (wt) or mutated
PS 0-2.
Evaluable disease according to RECIST criteria, i.e. the disease does not need to be measurable.
Haematology ANC ≥1.5x10^9/l. Thrombocytes ≥100x10^9/l.
Biochemistry Bilirubinaemia ≤ 3 x upper normal value. ALAT ≤ 5 x upper normal value.
Creatinin ≤ upper normal value. If raised creatinin, the measured or calculated GFR must be at least 50% of the lower normal value.
Fertile women must present a negative pregnancy test and use birth control during and 3 months after treatment. The following methods are considered safe birth control: Birth control pills, coil, gestagen deposit injection, subdermal implantation, hormonal vagina ring, and transdermal deposit band-aid)
Oral and written informed consent.

Exclusion Criteria:

Chemotherapy within 4 weeks
Radiotherapy within 4 weeks
Immunotherapy within 4 weeks
Other concomitant experimental treatment
Known neuropathy ≥ grade 2
Serious congruous medical disease
Other previous malignant disease within 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri
Previous serious and unexpected reactions to fluoropyrimidine treatment
Hypersensitivity to one or more of the active substances, auxiliary substances or fluoruracil
Patients with interstitial pneumonitis or pulmonary fibrosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779454

Contacts

Contact: Anders Jakobsen, Professor		anders.jakobsen@slb.regionsyddanmark.dk
Contact: Henrik Jensen, MD, PhD		lars.henrik.jensen@slb.regionsyddanmark.dk

Locations

Denmark
Vejle Hospital, Dept. of Oncology	Recruiting
Vejle, Denmark, DK-7100
Principal Investigator: Henrik Jensen, MD, Phd
Sub-Investigator: Anders Jakobsen, Prof., DMSc
The Finsen Center, Rigshospitalet	Recruiting
Copenhagen, Denmark, DK-2100
Contact: Ulrik Lassen, Consult. PhD ulassen@rh.dk
Principal Investigator: Ulrik Lassen, Consult. PhD

Sponsors and Collaborators

Vejle Hospital

More Information

Responsible Party:	( Professor, MD, DMSc )
Study ID Numbers:	EudraCT 2008-002367-14, S-20080081, 2612-3769
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00779454
Health Authority:	Denmark: National Board of Health

Keywords provided by Vejle Hospital:

KRAS

Study placed in the following topic categories:

Cholangiocarcinoma
Oxaliplatin
Capecitabine
Gemcitabine

Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 14, 2009