Pilot study of nab-Paclitaxel in combination with capecitabine as second line treatment of advanced biliary cancer.

Phase 2

Completed

• Conditions: advanced biliary cancer; Cancer - Biliary tree (gall bladder and bile duct)

• Registration Number: ACTRN12615000504516
• Lead Sponsor: Illawarra and Shoalhaven Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-20
• Study Completion: 2019-02-01
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of delivering second line treatment in advanced biliary cancer [Recruitment rate as measured by time taken to recruit 10 patients. The study aims to recruit 10 patients within 2 years.<br>];Safety and tolerability of treatment[As determined by incidence and severity of adverse events (toxicity). Toxicity assessments are done prior to each cycle of chemotherapy. ]

Secondary Outcome Measures

Name	Time	Method
Progression free survival is defined from date of registration on the study to the date of first evidence of disease progression.[Disease progression will be assessed by CT imaging at 6 weeks post registration and then every 12 weeks on treatment.];Overall survival[Overall survival is defined as interval from date of registration on the study to the date of death from any cause or last known date of follow up.];Patient reported Quality of Life[Quality of Life will be assessed using the EORTC QOL questionnaire prior to each cycle of chemotherapy and then at end of treatment and every 12 weeks thereafter.];Objective clinical benefit is defined as stable disease or better in response to the treatment. The tumour will be measured using by CT imaging by RECIST criteria.<br>[Tumour assessment by CT imaging is done 6 weeks post registration and every 12 weeks whilst on treatment.]