Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations

Phase 2

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab; Drug: Panitumumab

• Registration Number: NCT01206049
• Lead Sponsor: Vejle Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Combination chemotherapy + panitumumab	Gemcitabine	-
Combination chemotherapy + panitumumab	Oxaliplatin	-
Combination chemotherapy + bevacizumab	Capecitabine	-
Combination chemotherapy + bevacizumab	Bevacizumab	-
Combination chemotherapy + bevacizumab	Gemcitabine	-
Combination chemotherapy + panitumumab	Capecitabine	-
Combination chemotherapy + panitumumab	Panitumumab	-
Combination chemotherapy + bevacizumab	Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
The fraction of patients alive and without progression at 6 months	6 months from enrollment date

Secondary Outcome Measures

Name	Time	Method
Response rate before cross-over	6 months after enrollment or earlier in case of progression
Overall survival	6 months
Progression free survival and response rate after cross-over	6 months

Trial Locations

Locations (1)

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, Denmark