None listed
Conditions
Brief summary
This pilot study will determine the feasibility of a second line combination chemotherapy of NAB-Paclitaxel and capecitabine for the treatment of advance biliary cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have histologically proven unresectable biliary tract cancer and have had prior chemotherapy treatment with gemcitabine/platinum. Study Details: All participants will receive combination chemotherapy using NAB-Paclitaxel and Capecitabine for as long as their disease responds to treatment and will be followed up every 12 weeks (until death) after end of treatment with CT imaging, status and quality of life assessments in order to determine feasibility, clinical benefit, survival rates and impact of treatment on quality of life.
Interventions
Single arm, second line combination chemotherapy using nab-Paclitaxel and capecitabine. Nab-Paclitaxel (125mg/m2) will be administered intravenously (IV) on days 1 and 8 of each 21 day cycle. Capecitabine (825mg/m2) will be administered orally (PO) twice daily on days 1-14 of each 21 day cycle. Chemotherapy will continue until disease progression. Drug accountability checks will be performed prior to each cycle to monitor compliance.
Sponsors
Illawarra and Shoalhaven Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically proven unresectable biliary tract cancer 2. Prior chemotherapy with gemcitabine/platinum. Patient must have either progressed on chemotherapy or be intolerant to either drug. 3. >18 years 4. Measurable disease according to RECIST 5. Good performance status 6. Adequate bone marrow function 7. Adequate hepatic function 8. Adequate renal function 9 Planned to start treatment within 30 days of registration 10. Willing and able to comply with study requirements 11. Signed, written informed consent
Exclusion criteria
1. Previous treatment with a taxane or fluoropyrimidines 2. Prior hypersensitivity to paclitaxel or albumin 3. Significant underlying medical conditions that may be aggravated by study treatment 4. Significant peripheral neuropathy 5. Life expectancy of less than 3 months 6. Untreated brain metastases or leptomeningeal disease 7. History of another malignancy within 2 years prior to registration. 8. Concurrent illness including severe infection 9. Presence of any psychological, familial, sociological or geographical condition that may hamper compliance 10. Pregnancy, lactation, or inadequate contraception
Outcome results
None listed