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

NCT ID: NCT01206049

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination chemotherapy + panitumumab

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1,000 mg/m2 on day 1 of a 2 weeks cycle

Oxaliplatin

Intervention Type: DRUG

60 mg/m2 on day 1 of a 2 weeks cycle

Capecitabine

Intervention Type: DRUG

1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle

Panitumumab

Intervention Type: DRUG

6 mg/kg on day 1 of a 2 weeks cycle

Combination chemotherapy + bevacizumab

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

1,000 mg/m2 on day 1 of a 2 weeks cycle

Oxaliplatin

Intervention Type: DRUG

60 mg/m2 on day 1 of a 2 weeks cycle

Capecitabine

Intervention Type: DRUG

1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle

Bevacizumab

Intervention Type: DRUG

10 mg/kg on day 1 of a 2 weeks cycle

Interventions

Gemcitabine

1,000 mg/m2 on day 1 of a 2 weeks cycle

Intervention Type: DRUG

Oxaliplatin

60 mg/m2 on day 1 of a 2 weeks cycle

Intervention Type: DRUG

Capecitabine

1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle

Intervention Type: DRUG

Panitumumab

6 mg/kg on day 1 of a 2 weeks cycle

Intervention Type: DRUG

Bevacizumab

10 mg/kg on day 1 of a 2 weeks cycle

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Jakobsen, MD, DMSc

Role: STUDY_CHAIR

Department of Oncology, Vejle Hospital

Locations

Department of Oncology, Vejle Hospital

Vejle, , Denmark

Countries

Denmark

Other Identifiers

2010-020385-13

Identifier Type: -

Identifier Source: org_study_id