Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations (GOC-B-P)

March 9, 2017 updated by: Vejle Hospital

Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations

The purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. The patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, DK-7100
        • Department of Oncology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma
  • Minimum 18 years of age
  • Curative treatment currently not an option (operation, stereotactic radiation treatment or similar)
  • KRAS analyzed and found wild-type (wt)
  • Performance status 0-2
  • Evaluable disease according to RECIST, i.e. the disease need not be measurable
  • Hematology: ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l
  • Biochemistry: Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal level.
  • Creatinine ≤ upper normal level. At raised creatinine level the measured or calculated GFR must be at least 50% of the lower normal level
  • Fertile women must present a negative pregnancy test and use secure birth control during and 6 months after treatment. Men with fertile partners must also take care of secure birth control.
  • Written and orally informed consent

Exclusion Criteria:

  • Previous cytostatic treatment of inoperable cholangiocarcinoma
  • Adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start
  • Other concomitant experimental treatment
  • Severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator
  • Other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri
  • Interstitial pneumonitis or subsequent pulmonary fibrosis
  • Pregnant or breastfeeding women
  • Large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment.
  • Significant non-healing wound or ulcers
  • Active hemorrhage or increased risk of hemorrhage (e.g. tumor invasion in large vessels or known esophagus varices)
  • Known hypersensitivity to panitumumab, bevacizumab or any of the auxiliary agents
  • Grade IV fistulas
  • Uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilized hypertension >160/100
  • Haemoptysis > 2.5 ml within 2 weeks prior to enrolment
  • Previous serious and unexpected reactions or know hypersensitivity to two or more of the applied cytostatics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination chemotherapy + panitumumab
Drug: Gemcitabine
1,000 mg/m2 on day 1 of a 2 weeks cycle
Drug: Oxaliplatin
60 mg/m2 on day 1 of a 2 weeks cycle
Drug: Capecitabine
1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
Drug: Panitumumab
6 mg/kg on day 1 of a 2 weeks cycle
Experimental: Combination chemotherapy + bevacizumab
Drug: Gemcitabine
1,000 mg/m2 on day 1 of a 2 weeks cycle
Drug: Oxaliplatin
60 mg/m2 on day 1 of a 2 weeks cycle
Drug: Capecitabine
1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
Drug: Bevacizumab
10 mg/kg on day 1 of a 2 weeks cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The fraction of patients alive and without progression at 6 months
Time Frame: 6 months from enrollment date
6 months from enrollment date

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 6 months
6 months
Response rate before cross-over
Time Frame: 6 months after enrollment or earlier in case of progression
6 months after enrollment or earlier in case of progression
Progression free survival and response rate after cross-over
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-020385-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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