Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread

Conditions

• Metastatic Pancreatic Adenocarcinoma
• Stage IV Pancreatic Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

70 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorouracil — DRUG
  Given IV
• Gemcitabine — DRUG
  Given IV
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Leucovorin — DRUG
  Given IV
• Leucovorin Calcium — DRUG
  Given IV
• Liposomal Irinotecan — DRUG
  Given IV
• Nab-paclitaxel — DRUG
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.

Key Dates

Start date

Aug 26, 2020

Status verified

Apr 2026

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

176 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (gemcitabine, nab-paclitaxel)
  Patients receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (fluorouracil, leucovorin, liposomal irinotecan)
  Patients receive fluorouracil IV over 46 hours starting on day 1. Patients also receive leucovorin IV over 90-120 minutes and liposomal irinotecan IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to 2 years post treatment ]

Locations (760)

Find similar trials in Birmingham, AL

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