NCT03535727

A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer

A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.

Detailed description

This was a two-part, single-institution, open-label, dose-escalation, phase 1/2 study to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan in patients with metastatic pancreatic cancer. Part 1 of the study was a Phase 1 3 + 3 dose escalation study designed to evaluate the maximally tolerated dose (MTD) and safety of increasing doses of nab-paclitaxel in combination with gemcitabine, capecitabine, cisplatin, and irinotecan. There were two cohorts of dose escalations. The two cohorts differed based on the treatment cycle length (28 days for Cohort 1 and 21 days for Cohort 2). Dose escalation started with Cohort 1. Enrollment for Cohort 2 dose level 1 began once dose level 2 of Cohort 1 was shown to be safe and did not exceed MTD. Part 2 was a Phase 2 expansion cohort study for the evaluation of efficacy once the MTD had been determined.

Conditions

• Adenocarcinoma
• Pancreatic Neoplasms
• Neoplasm, Glandular
• Neoplasms
• Neoplasms Pancreatic
• Digestive System Neoplasm
• Endocrine Gland Neoplasms
• Digestive System Disease
• Pancreatic Diseases
• Endocrine System Diseases

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel	IV over 30 minutes; Days 1 and 15
DRUG	Gemcitabine	IV over 30 minutes; Days 1 and 15
DRUG	Capecitabine	PO twice daily (BID); Days 1-7, 15-21
DRUG	Cisplatin	IV over 60 minutes; Days 1 and 15
DRUG	Irinotecan	IV over 30 minutes; Days 1 and 15
DRUG	Nab-paclitaxel	IV over 30 minutes; Days 4 and 11
DRUG	Gemcitabine	IV over 30 minutes; Days 4 and 11
DRUG	Capecitabine	PO BID; Days 1- 14
DRUG	Cisplatin	IV over 60 minutes; Days 4 and 11
DRUG	Irinotecan	IV over 30 minutes; Days 4 and 11

Timeline

• Start date: 2018-06-21
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2018-05-24
• Last updated: 2024-12-31
• Results posted: 2024-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study