Prospective observational cohort study of advanced Gall bladder cancer patients to study the impact of clinical and molecular characteristics and outcome

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

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