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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vejle Hospital
• Treatments: Antibodies, Monoclonal; Bevacizumab; Capecitabine; Gemcitabine; Oxaliplatin; Panitumumab

Criteria

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