Overview

This trial is active, not recruiting.

Condition cholangiocarcinoma
Treatments gemcitabine, oxaliplatin, capecitabine, panitumumab, bevacizumab
Phase phase 2
Targets EGFR, VEGF
Sponsor Vejle Hospital
Start date September 2010
End date March 2016
Trial size 78 participants
Trial identifier NCT01206049, 2010-020385-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
gemcitabine
1,000 mg/m2 on day 1 of a 2 weeks cycle
oxaliplatin
60 mg/m2 on day 1 of a 2 weeks cycle
capecitabine
1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
panitumumab
6 mg/kg on day 1 of a 2 weeks cycle
(Experimental)
gemcitabine
1,000 mg/m2 on day 1 of a 2 weeks cycle
oxaliplatin
60 mg/m2 on day 1 of a 2 weeks cycle
capecitabine
1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
bevacizumab
10 mg/kg on day 1 of a 2 weeks cycle

Primary Outcomes

Measure
The fraction of patients alive and without progression at 6 months
time frame: 6 months from enrollment date

Secondary Outcomes

Measure
Response rate before cross-over
time frame: 6 months after enrollment or earlier in case of progression
Overall survival
time frame: 6 months
Progression free survival and response rate after cross-over
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Phase II Trial of Combination Chemotherapy With Panitumumab or Bevacizumab for Patients With Inoperable Cholangiocarcinoma Without KRAS Mutations
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Vejle Hospital.