Health Condition 1: C221- Intrahepatic bile duct carcinoma Health Condition 2: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 3: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: TARGETED THERAPY: Arm A. Trastuzumab plus GemCis/Ox for Her2neu amplification (standard dose Trastuzumab 1st cycle 8mg/kg, followed by 6 mg/kg every 3 weeks)
Arm B. Trastuzumab and Lap
Sponsors
Armed Forces Medical Research Committee
Eligibility
Inclusion criteria
Inclusion criteria: Histologically proven cases of adenocarcinoma of gallbladder and Cholangiocarcinoma. Locally advanced, unresectable or metastatic disease ECOG Performance status Adequate bone marrow function reflected Hemoglobin > 8 gm/dl, TLC > 4,000/cumm (ANC >1,500/cumm), and Platelets >1,00,000/cumm) Serum creatinine Serum bilirubin Liver enzymes (SGOT and SGPT) within 3 times the upper normal limit No prior exposure to gemcitabine, Oxaliplatin, cisplatin, capecitabine or radiation therapy
Exclusion criteria
Exclusion criteria: Women of reproductive age group not practicing contraception. Lactating and pregnant women. History of previous carcinoma in last 5 yrs. Active hepatitis B, C or HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate,Timepoint: 03 months, 06 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survivalTimepoint: 03 months, 06 months, 01 year. | — |
Countries
India
Contacts
Public ContactAMOL PATEL
ARMY HOSPITAL RESEARCH REFERRAL NEW DELHI
Outcome results
None listed