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Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Gemcitabine, Oxaliplatin, Capecitabine,
Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring KRAS wild-type, Cholangiocarcinoma, Inoperable

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 1.5 x 10^9/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

Sites / Locations

  • Vejle Hospital, Dept. of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

KRAS wildtype

KRAS mutation

Arm Description

Inclusion has been completed in the KRAS mutation arm.

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Response rate
Overall survival

Full Information

First Posted
October 22, 2008
Last Updated
February 4, 2020
Sponsor
Vejle Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00779454
Brief Title
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Official Title
Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 Kirsten rat sarcoma viral oncogene homolog (KRAS).
Detailed Description
Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 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. Approximately 50% of the patients present this mutation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
KRAS wild-type, Cholangiocarcinoma, Inoperable

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KRAS wildtype
Arm Type
Other
Arm Title
KRAS mutation
Arm Type
Other
Arm Description
Inclusion has been completed in the KRAS mutation arm.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Oxaliplatin, Capecitabine,
Intervention Description
Gemcitabin: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7
Intervention Type
Drug
Intervention Name(s)
Panitumumab, Gemcitabine, Oxaliplatin, Capecitabine
Intervention Description
Gemcitabine: 1,000 mg/m2 day 1 Oxaliplatin: 60 mg/m2 day 1 Capecitabine: 1,000 mg/m2 x 2 daily days 1-7 Panitumumab: 6 mg/kg day 1
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
6 months
Title
Overall survival
Time Frame
6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 ≥ 1.5 x 10^9/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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jakobsen, DMSc
Organizational Affiliation
Vejle Hospital, Vejle, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital, Dept. of Oncology
City
Vejle
ZIP/Postal Code
DK-7100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31838939
Citation
Jensen LH, Andersen RF, Byriel L, Fernebro E, Jakobsen A, Lindebjerg J, Nottelmann L, Ploen J, Hansen TF. Phase II study of gemcitabine, oxaliplatin and capecitabine in patients with KRAS exon 2 mutated biliary tract cancers. Acta Oncol. 2020 Mar;59(3):298-301. doi: 10.1080/0284186X.2019.1701201. Epub 2019 Dec 14.
Results Reference
derived
PubMed Identifier
22367707
Citation
Jensen LH, Lindebjerg J, Ploen J, Hansen TF, Jakobsen A. Phase II marker-driven trial of panitumumab and chemotherapy in KRAS wild-type biliary tract cancer. Ann Oncol. 2012 Sep;23(9):2341-2346. doi: 10.1093/annonc/mds008. Epub 2012 Feb 23.
Results Reference
derived

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Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

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