Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified
Conditions
Interventions
Intervention1: Bevacizumab plus Erlotinib: Arm A Bevacizumab plus Erlotinib)
Dose : Bevacizumab 5 mg/m2 IV over 90 mins, q every 21 days (subsequent administrations over 60 minutes if initial admini
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications – Biliary tract cancers including gallbladder cancer, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma Received palliative gemcitabine based chemotherapy (Gemcitabine- cisplatin /gemcitabine-oxaliplatin /gemcitabine/gemcitabine-capecitabine) for 6 months and having at least stable disease on response evaluation (clinically and radiologically) for at least 2 months prior to inclusion in study. 2) ECOG performance status 0 - 1 3) Patient who can give informed consent for the study. 4) Patient does not have any contraindications to receive chemotherapy, bevacizumab or erlotinib 5) Adequate hematological, hepatic and renal function parameters• 7) Women of childbearing 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. 8) No major surgery within last 4 weeks 9) Written patient consent form
Exclusion criteria
Exclusion criteria: 1. Distal cholangiocarcinoma which would be considered as ampullary carcinomas 2. Known hypersensitivity or contraindications against bevacizumab or erlotinib. 3. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA II-IV, 4. Clinically significant valvular defect 5. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix 6. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy 7. Other severe internal disease or acute infection 8. Baseline neuropathy more NCI Grade II 9. Chronic inflammatory bowel disease 10. Unhealed surgical wounds 11. Severe hemorrhage 12. Recent hemoptysis 13. History of GI perforation 14. Uncontrolled hypertension 15. Severe/arterial thromboembolism 16. On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study 17. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II - To evaluate difference in progression free survival at 6 months and 1 year between bevacizumab-erlotinib (switch maintenance) and observation post 6 months of 1st line gemcitabine based chemotherapy Phase III - To evaluate difference in overall survival at 6 months and 1 year between bevacizumab-erlotinib (switch maintenance) and observation post 6 months of 1st line gemcitabine based chemotherapy Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate difference in overall survival To evaluate difference in response rates To evaluate differences in quality of life scales To evaluate differences in time to deterioration of ECOG PS and time to deterioration of HR-QOL scalesTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactAnant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed