Capecitabine and oxaliplatin combination chemotherapy in gall bladder or biliary tract cancer patients

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Biliary Tract, Gall Bladder; Cancer; Gall bladder cancer

• Registration Number: ISRCTN40839737
• Lead Sponsor: HS Greater Glasgow and Clyde

Brief Summary

2016 results in: ncbi.nlm.nih.gov/pubmed/26969121 (added 28/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-01-20
• Study Start: 2010-04-29
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Histologically or cytologically proven adenocarcinoma of the gall bladder or biliary tract
2. Inoperable disease as determined by radiological assessment, laparotomy or laparoscopy
3. At least one site of unidimensional measurable disease. Lesions must be at least 10 mm in diameter if measured on a spiral computed tomography (CT) scan.
4. Performance status greater than or equal to 2 (Eastern Cooperative Oncology Group [ECOG])
5. Adequate renal function (serum creatinine less than 1.5 x the upper limit of the normal reference range) and creatinine clearance greater than 50 ml/min as calculated by the Cockroft-Gault formula. Patients with creatinine clearance less than or equal to 50 mL/min by the Cockroft-Gault formula are eligible if the creatinine clearance is greater than 50 mL/min if measured by an EDTA assessment.
6. Written informed consent
7. Aged greater than 18 years, either sex
8. No prior chemotherapy for advanced disease
9. Able to reliably tolerate and comply with oral medication (capecitabine)

Exclusion Criteria

1. Any evidence of uncontrolled cardiac disease or any other serious medical or psychiatric disorder that would be a contra-indication for prescribing this chemotherapy regimen
2. Pregnancy. Women of child-bearing potential not taking adequate contraception, and women who are breast feeding will also be excluded.
3. No prior or concurrent malignancy other than basal cell carcinoma of the skin or in situ neoplasia of the cervix uteri
4. Inadequate haematological function as defined by:
4.1. Haemoglobin (Hb) less than 10 g/dl
4.2. Neutrophil count less than 1.5 x 10^9/l
4.3. Platelets less than 100 x 10^9/l
5. Deranged liver function tests: serum bilirubin greater than 2.5 x upper limit of normal reference range for laboratory; transaminases greater than 5 x upper limit of normal reference range
6. Life expectancy less than 3 months
7. Any chemotherapy, radiotherapy, hormonal or immunotherapy within the last 4 weeks
8. Patients with a lack of physical integrity of the gastrointestinal (GI) tract leading to a malabsorption syndrome or intestinal obstruction that would impair administration or absorption of oral therapy
9. Patients with greater than grade 1 peripheral sensory neuropathy
10. Patients with known sensitivity to fluoropyrimidines or oxaliplatin

Study & Design

• Study Type: Interventional
• Study Design: Not specified