Health Condition 1: null- Gall Bladder Health Condition 2: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: Capecitabine plus Irinotecan Doublet Chemotherapy: 1) Arm 1 to 3 weekly Capecitabine (1700â??mgâ??mâ??2, P.O, on days 1â??14 q 21 days) plus Irinotecan (200â??mgâ??mâ??2, iv, on day 1 q
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patient with advanced unresectable or metastatic GBC cancer that is not amenable to curative intent therapy. 2) Patients should have been treated with palliative intent first line chemotherapy and should have progressed on the same, or stopped 1st line chemotherapy due to poor tolerance, adverse events or other reasons. 3) Age 18 to 70 years. 4) ECOG performance status 0, 1. 5) If the patient has been treated with curative intent therapy, this therapy should have been completed at least 6 months prior to enrolment. 6) Patient who can give informed consent for the study. 7) Patient does not have any contraindications to receive chemotherapy 8) Adequate organ function 1)Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L. 2)Liver functions- bilirubin = 30 g/L 3)Renal function- Creatinine 50 mL/min. 9) Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
Exclusion criteria
Exclusion criteria: 1) Serious co-morbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections. 2) History of treatment with 5 FU, Capecitabine or Irinotecan 3) Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable. 4) Patients on other investigational drugs within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate if second line palliative doublet chemotherapy prolongs overall survival in patients with advanced unresectable or metastatic gall bladder cancers (GBC) after progression on first line chemotherapy in comparison to palliative monotherapyTimepoint: Two and half years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Evaluate whether doublet palliative chemotherapy prolongs EFS 2)Improves quality of life 3)Response rate 4)factors that can predict which patients are more likely to benefit from second line palliative 5)Rate of adverse events and perform safety analysis 6)Time to deterioration of ECOG performance statusTimepoint: Two and half years | — |
Countries
India
Contacts
Public ContactAnant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed