NCT01206049
Completed
Phase 2
Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations
ConditionsCholangiocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine
- Conditions
- Cholangiocarcinoma
- Sponsor
- Vejle Hospital
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- The fraction of patients alive and without progression at 6 months
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
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)
Arms & Interventions
Combination chemotherapy + panitumumab
Intervention: Gemcitabine
Combination chemotherapy + panitumumab
Intervention: Oxaliplatin
Combination chemotherapy + panitumumab
Intervention: Capecitabine
Combination chemotherapy + panitumumab
Intervention: Panitumumab
Combination chemotherapy + bevacizumab
Intervention: Gemcitabine
Combination chemotherapy + bevacizumab
Intervention: Oxaliplatin
Combination chemotherapy + bevacizumab
Intervention: Capecitabine
Combination chemotherapy + bevacizumab
Intervention: Bevacizumab
Outcomes
Primary Outcomes
The fraction of patients alive and without progression at 6 months
Time Frame: 6 months from enrollment date
Secondary Outcomes
- 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)
Study Sites (1)
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