Pilot study of nab-Paclitaxel in combination with capecitabine as second line treatment of advanced biliary cancer.
Patients with advanced biliary cancer to be treated with second line combination chemotherapy of NAB Paclitaxel and capecitabine in a single arm pilot study to assess feasibility
Illawarra and Shoalhaven Local Health District
10 participants
Aug 12, 2015
Interventional
Conditions
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.
Eligibility
Inclusion Criteria11
- Histologically proven unresectable biliary tract cancer
- Prior chemotherapy with gemcitabine/platinum. Patient must have either progressed on chemotherapy or be intolerant to either drug.
- >18 years
- Measurable disease according to RECIST
- Good performance status
- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
- Planned to start treatment within 30 days of registration
- Willing and able to comply with study requirements
- Signed, written informed consent
Exclusion Criteria10
- Previous treatment with a taxane or fluoropyrimidines
- Prior hypersensitivity to paclitaxel or albumin
- Significant underlying medical conditions that may be aggravated by study treatment
- Significant peripheral neuropathy
- Life expectancy of less than 3 months
- Untreated brain metastases or leptomeningeal disease
- History of another malignancy within 2 years prior to registration.
- Concurrent illness including severe infection
- Presence of any psychological, familial, sociological or geographical condition that may hamper compliance
- Pregnancy, lactation, or inadequate contraception
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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.
Locations(4)
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ACTRN12615000504516