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Clinical Trials/ACTRN12615000504516
ACTRN12615000504516
Completed
Phase 2

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 District0 sites10 target enrollmentMay 20, 2015
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Conditionsadvanced biliary cancerCancer - Biliary tree (gall bladder and bile duct)

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
advanced biliary cancer
Sponsor
Illawarra and Shoalhaven Local Health District
Enrollment
10
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 20, 2015
End Date
February 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Illawarra and Shoalhaven Local Health District

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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