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

ID#: NCT04005339

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: July 29, 2019

End Date: July 31, 2024

Summary: This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.
Eligibility:

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
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