NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

Inclusion Criteria: * Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic * Disease progression on or intolerance of gemcitabine- and platinum-based chemotherapy * No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count) * Measurable disease by RECIST v1.1 criteria * ECOG performance status of 0-1 * At least 18 years of age * HIV-positive patients are eligible provided: Stable HAART regimen, No concurrent prophylactic antibiotics or antifungals, and CD4 count above 250 and undetectable viral load * Adequate bone marrow, hepatic, and renal function * Consent to access archived tumor tissue if available (available tissue is not required for enrollment) Exclusion Criteria: * Ampullary adenocarcinoma * Woman who are pregnant or breastfeeding * Anti-cancer treatment within 3 weeks prior to enrollment * Prior irinotecan or nanoliposomal irinotecan * Central nervous system metastases unless stable for at least 4 weeks and at least 2 weeks off corticosteroids * Exposure to a strong CYP3A4 inducer, strong CYP3A4 inhibitor, or strong UGT1A1 inhibitor within 2 weeks of study start * Known concurrent malignancy or other malignancy within 3 years except for non-melanomatous skin cancers, prostate or cervical cancers following curative therapy, or superficial bladder cancer * Bowel obstruction * Allergy or hypersensitivity to fluoropyrimidines, irinotecan, or nanoliposomal irinotecan * Clinically significant liver disease: Patients with resolved hepatitis B infection are eligible if HBsAg testing is negative; Patients with resolved hepatitis C infection are eligible if viral RNA PCR is negative * Severe infections within 4 weeks prior to enrollment * Major surgery within 4 weeks prior to enrollment