Topic: National Cancer Research Network
Conditions
Interventions
1. Capecitabine, twice daily (BID) for 14 days every 21 days, 1000 mg/m^2
2. Oxaliplatin, once daily (OD) once every 21 days, 130 mg/m^2
Duration of treatment was 18 w
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (complete and partial) by RECIST of capecitabine and oxaliplatin combination, assessed after 13 patients recruited. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured after 43 patients are recruited: 1. Toxicity 2. Progression-free survival 3. Overall survival | — |
Countries
United Kingdom
Outcome results
None listed