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

Vejle Hospital

Status and phase: Completed; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Drug: Panitumumab; Drug: Bevacizumab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01206049

2010-020385-13

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Combination chemotherapy + panitumumab

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Panitumumab

Drug: Capecitabine

Drug: Oxaliplatin

Combination chemotherapy + bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: Gemcitabine

Drug: Capecitabine

Drug: Oxaliplatin