Biliary Cancer
Conditions
Keywords
biliary cancer, irinotecan, cisplatin, gemcitabine
Brief summary
To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.
Interventions
DRUGIrinotecan
Irinotecan 65mg/m² D1 and D8 q21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.
DRUGCisplatin
Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.
DRUGGemcitabine
Gemcitabine 1000mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity. Given in association with standard hydration and anti-emetics.
Sponsors
Hospital de Cancer de Barretos - Fundacao Pio XII
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* biopsy-proven gallbladder or biliary tract cancer; * Recurrent, metastatic or unresectable disease; * Chemo-naïve. * Not candidates to curative-intent treatment, such as surgery or radiation-therapy; * Measurable disease according to RECIST 1.1; * ECOG 0-2; * Adequate hematologic and biochemistry tests; * Creatinine clearance \>= 60ml/min.
Exclusion criteria
* Known hypersensibility or previous therapy with cisplatin, gemcitabine or irinotecan; * Chronic immunosuppressive therapy; * Known CNS metastasis; * Previous diagnosis of other cancer; * Chronic or acute active infection, except asymptomatic HIV infection; * Active bleeding; * Any severe medical condition; * Pregnant or lactating women, or with childbearing potential;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Up to 24 weeks from randomization | The overall response rate will measure the number of subjects with complete or partial response as best response during the entire treatment, over the total number of subjects, for each arm. The response will be evaluated according to RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 6mo after the last enrolled patient | We will measure the number of subjects without progressive disease (complete response, partial response or stable disease) or any-cause death, whichever came first. For each patient, PFS will be calculated from randomization until progressive disease. Disease progression means radiologic progression per RECIST 1.1 or any-cause death. PFS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median PFS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the PFS rate at one and two years will be calculated. |
| Overall Survival (OS) | 6mo after the last enrolled patient | We will measure the number of subjects without any-cause death. For each patient, OS will be calculated from randomization until death. OS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median OS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at one and two years will be calculated. |
| Disease Control Rate | Up to 6 weeks from randomization | The disease control rate will measure the number of subjects with complete or partial response, or disease stabilization as best response during the entire treatment, over the total number of subjects, for each arm. The response will be evaluated according to RECIST 1.1. |
| Safety | 6 mo after the last enrolled patients | Safety and tolerability will be assessed using NCI CTCAE v3. The number of patients in each arm experiencing any grade Adverse Events (for each AE) and Serious AE (SAE) over the total number of subjects will be measured, and the proportion of patients experiencing AE in each arm will be compared using uncorrected chi-sq test. AE will be recorded in baseline and in each visit, and the worst grade AE will be considered. Each AE will be classified in grades 1-2, 3-4 and SAE. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarker evaluation | Baseline | The following biomarkers will be tested by immunohistochemistry: human equilibrative nucleoside transporter (hENT), X-ray repair cross-complementing protein 1 (XRCC1), Excision repair cross-complementing rodent repair deficiency, complementation group 1 (ERCC1) e mLH1. Then we will correlate them with efficacy end-points using non-parametric test. |
Countries
Brazil
Contacts
Primary ContactLucas V dos Santos, MD
Backup ContactKathia C Abdalla, MD
Outcome results
None listed