Combination treatment for advanced biliary tract cancer
NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer
This study is testing a new combination of cancer drugs to see if it can help people with advanced biliary tract cancer who haven't responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Georgetown University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Washington, District of Columbia and 3 other locations) |
| Trial ID | NCT04005339 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as a second-line treatment for patients with advanced biliary tract cancers who have previously undergone gemcitabine and platinum chemotherapy. It is a single-arm, open-label, multicenter phase II trial that includes patients with unresectable or metastatic biliary tract cancer. Participants will be monitored for treatment response using imaging every 8 weeks, and they can continue treatment as long as they tolerate it and do not show disease progression.
Who should consider this trial
Good fit: Ideal candidates are adults with pathologically-confirmed advanced biliary tract cancer who have experienced disease progression on gemcitabine and platinum-based chemotherapy.
Not a fit: Patients with ampullary adenocarcinoma or those who have received prior irinotecan or nanoliposomal irinotecan will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced biliary tract cancer who have limited treatment choices.
How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington, District of Columbia and 3 other locations
- Lombardi Comprehensive Cancer Center, Georgetown University — Washington, District of Columbia, United States (Recruiting)
- Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (Active_not_recruiting)
- Washington University School of Medicine- Siteman Cancer Center — Saint Louis, Missouri, United States (Active_not_recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.