Health Condition 1: null- Gall Bladder cancer Health Condition 2: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
None listed
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patients must have histologically confirmed locally advanced inoperable or metastatic adenocarcinoma of the gallbladder who have not previously received any systemic treatment for their disease ECOG performance status 0-2. Patients must have adequate organ and marrow function as defined below: WBC at least 4,000/cmm ANC at least 2000/cmm PLT at least 150,000/cmm Total bilirubin must be less than 2.5 x institutional upper limit of norm AST(SGOT)/ALT(SGPT) must be less than 5 X institutional upper limit of normal Creatinine clearance must be greater than 50 mL/min as calculated by the Cockroft-Gault formula At least one measurable lesion as defined by RECIST criteria
Exclusion criteria
Exclusion criteria: No concomitant radiation therapy or other systemic cancer therapies. History of allergy to platinum compounds, capecitabine, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months, symptomatic congestive heart failure, unstable angina pectoris within 3 months prior to entry study, myocardial infarction within 6 months prior to study entry, ongoing cardiac arrhythmia (excluding atrial fibrillation), uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management),HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the study because of possible pharmacokinetic interactions. Second malignancy within the past 3 years (excluding nonmelanoma skin cancer and in situ cancers) that has not been treated with curative intent and is not currently without evidence of disease, Patients with known gastrointestinal malabsorption syndromes are excluded as this concurrent illness will affect absorption of the oral medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the overall survival among patients in relation to different markers .And to find out combination of the prognostic and predictive markers in relation to overall survivalTimepoint: 3 year | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the progression free survival among in relation to different markersTimepoint: 3 year | — |
Countries
India
Contacts
Public ContactVikas Ostwal
Tata Memorial Hospital
Outcome results
None listed