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

NCT03535727 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-31

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Dung Le, MD · Johns Hopkins Medical Institution

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2022-10-03
Completion
2022-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535727 on ClinicalTrials.gov