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