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

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Georgetown University
• Collaborator: Ipsen
• Treatments: Fluorouracil; Irinotecan; Leucovorin

Criteria

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