Maintenance bevacizumab plus erlotinib versus observation in advanced Billiary tract cancer
- Conditions
- Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified
- Registration Number
- CTRI/2020/03/023943
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>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 <br/ ><br>Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method To evaluate difference in overall survival <br/ ><br>To evaluate difference in response rates <br/ ><br>To evaluate differences in quality of life scales <br/ ><br>To evaluate differences in time to deterioration of ECOG PS and time to deterioration of HR-QOL scalesTimepoint: 1 year