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

NCT ID: NCT03535727

Last Updated: 2024-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2022-10-03

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1, Cohort 1, Dose level 1

Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Nab-paclitaxel: 40 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle

Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle

Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Capecitabine

Intervention Type DRUG

PO twice daily (BID); Days 1-7, 15-21

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 1 and 15

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Phase 1, Cohort 1, Dose level 2

Gemcitabine 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Nab-paclitaxel 60 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Capecitabine: 500 mg BID: PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle

Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle

Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Capecitabine

Intervention Type DRUG

PO twice daily (BID); Days 1-7, 15-21

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 1 and 15

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Phase 1, Cohort 1, Dose level 3

Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Nab-paclitaxel: 80 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle

Cisplatin 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle

Irinotecan:20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Capecitabine

Intervention Type DRUG

PO twice daily (BID); Days 1-7, 15-21

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 1 and 15

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Phase 1, Cohort 1, Dose level 4

Gemcitabine:500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Nab-paclitaxel:100 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Capecitabine:500 PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle

Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle

Irinotecan:20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Capecitabine

Intervention Type DRUG

PO twice daily (BID); Days 1-7, 15-21

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 1 and 15

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Phase 1, Cohort 1, Dose level 5

Gemcitabine:500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Nab-paclitaxel:125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle

Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle

Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Capecitabine

Intervention Type DRUG

PO twice daily (BID); Days 1-7, 15-21

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 1 and 15

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Phase 1, Cohort 2, Dose level 1

Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Nab-paclitaxel:40 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle

Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle

Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Capecitabine

Intervention Type DRUG

PO BID; Days 1- 14

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 4 and 11

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Phase 1, Cohort 2, Dose level 2

Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Nab-paclitaxel:60 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle

Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle

Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Capecitabine

Intervention Type DRUG

PO BID; Days 1- 14

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 4 and 11

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Phase 1, Cohort 2, Dose level 3

Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Nab-paclitaxel:80 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle

Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle

Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Capecitabine

Intervention Type DRUG

PO BID; Days 1- 14

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 4 and 11

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 4 and 11

Phase 2 Dose Expansion (Cohort 1, DL5)

Gemcitabine:500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Nab-paclitaxel:125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle

Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle

Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle

Group Type EXPERIMENTAL

Nab-paclitaxel

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Gemcitabine

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Capecitabine

Intervention Type DRUG

PO twice daily (BID); Days 1-7, 15-21

Cisplatin

Intervention Type DRUG

IV over 60 minutes; Days 1 and 15

Irinotecan

Intervention Type DRUG

IV over 30 minutes; Days 1 and 15

Interventions

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Nab-paclitaxel

IV over 30 minutes; Days 1 and 15

Intervention Type DRUG

Gemcitabine

IV over 30 minutes; Days 1 and 15

Intervention Type DRUG

Capecitabine

PO twice daily (BID); Days 1-7, 15-21

Intervention Type DRUG

Cisplatin

IV over 60 minutes; Days 1 and 15

Intervention Type DRUG

Irinotecan

IV over 30 minutes; Days 1 and 15

Intervention Type DRUG

Nab-paclitaxel

IV over 30 minutes; Days 4 and 11

Intervention Type DRUG

Gemcitabine

IV over 30 minutes; Days 4 and 11

Intervention Type DRUG

Capecitabine

PO BID; Days 1- 14

Intervention Type DRUG

Cisplatin

IV over 60 minutes; Days 4 and 11

Intervention Type DRUG

Irinotecan

IV over 30 minutes; Days 4 and 11

Intervention Type DRUG

Other Intervention Names

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Abraxane Gemzar Xeloda Platinol Camptosar Abraxane Gemzar Xeloda Platinol Camptosar

Eligibility Criteria

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Inclusion Criteria

* Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
* Patients with the presence of at least one measurable lesion.
* Male or non-pregnant and non-lactating female of age \>18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

* Patients who will be considered for surgery are ineligible.
* Patient who have had any prior chemotherapy within 5 years of enrollment.
* Patient who have had radiotherapy for pancreatic cancer.
* Age ≥ 76 years
* Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
* Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
* Patient who has known brain metastases.
* Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan.
* Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patient who has serious medical risk factors involving any of the major organ systems.
* Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
* Pregnant or breast feeding.
* Patient is unwilling or unable to comply with study procedures
* Patient with clinically significant wound.
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dung Le, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Institution

Locations

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Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB00167664

Identifier Type: OTHER

Identifier Source: secondary_id

J1847

Identifier Type: -

Identifier Source: org_study_id