NCT02324543

Brief Summary

This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 14, 2020

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

4.3 years

First QC Date

December 19, 2014

Results QC Date

June 24, 2020

Last Update Submit

July 17, 2023

Conditions

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (6)

  • Maximum Tolerated Dose (MTD) of Gemcitabine

    Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.

    28 days

  • Maximum Tolerated Dose (MTD) of Docetaxel

    Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.

    28 days

  • Maximum Tolerated Dose (MTD) of Capecitabine

    Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use.

    28 days

  • Maximum Tolerated Dose (MTD) of Cisplatin

    Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.

    28 days

  • Maximum Tolerated Dose (MTD) of Irinotecan

    Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.

    28 days

  • Overall Survival (OS) Rate at 9 Months

    OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only)

    9 months

Secondary Outcomes (4)

  • Response Rate (RR) Using RECIST 1.1 Criteria

    43 months

  • Disease Control Rate (DCR) Using RECIST 1.1 Criteria

    43 months

  • Progression-free Survival (PFS) Using RECIST 1.1 Criteria

    5 years

  • Overall Survival (OS)

    5 years

Study Arms (6)

Dose level 1 - Phase 1

EXPERIMENTAL

* Gemcitabine - 400 mg/m\^2 * Taxotere - 20 mg/m\^2 * Xeloda - 500 mg/twice daily (BID) * Cisplatin - 15 mg/m\^2 * Irinotecan - 20 mg/m\^2

Drug: GemcitabineDrug: TaxotereDrug: XelodaDrug: CisplatinDrug: Irinotecan

Dose Level 2 - Phase 1

EXPERIMENTAL

* Gemcitabine - 400 mg/m\^2 * Taxotere - 20 mg/m\^2 * Xeloda - 500 mg/BID * Cisplatin - 15 mg/m\^2 * Irinotecan - 40 mg/m\^2

Drug: GemcitabineDrug: TaxotereDrug: XelodaDrug: CisplatinDrug: Irinotecan

Dose Level 3 - Phase 1

EXPERIMENTAL

* Gemcitabine - 400 mg/m\^2 * Taxotere - 20 mg/m\^2 * Xeloda - 500 mg/BID * Cisplatin - 15 mg/m\^2 * Irinotecan - 60 mg/m\^2

Drug: GemcitabineDrug: TaxotereDrug: XelodaDrug: CisplatinDrug: Irinotecan

Dose Level 1a - Phase 1

EXPERIMENTAL

* Gemcitabine - 500 mg/m\^2 * Taxotere - 20 mg/m\^2 * Xeloda - 500 mg/BID * Cisplatin - 20 mg/m\^2 * Irinotecan - 20 mg/m\^2

Drug: GemcitabineDrug: TaxotereDrug: XelodaDrug: CisplatinDrug: Irinotecan

Dose level 1b - Phase 1

EXPERIMENTAL

* Gemcitabine - 500 mg/m\^2 * Taxotere - 20 mg/m\^2 * Xeloda - 500 mg/BID * Cisplatin - 20 mg/m\^2 * Irinotecan - 40 mg/m\^2

Drug: GemcitabineDrug: TaxotereDrug: XelodaDrug: CisplatinDrug: Irinotecan

Phase 2

EXPERIMENTAL

* Gemcitabine - 500 mg/m\^2 * Taxotere - 20 mg/m\^2 * Xeloda - 500 mg/BID * Cisplatin - 20 mg/m\^2 * Irinotecan - 20 mg/m\^2

Drug: GemcitabineDrug: TaxotereDrug: XelodaDrug: CisplatinDrug: Irinotecan

Interventions

GemcitabineDRUG

IV on days 4 and 11 of a 21 day cycle

Also known as: Gemzar
Dose Level 1a - Phase 1Dose Level 2 - Phase 1Dose Level 3 - Phase 1Dose level 1 - Phase 1Dose level 1b - Phase 1Phase 2
TaxotereDRUG

IV on days 4 and 11 of a 21 day cycle

Also known as: Docetaxel
Dose Level 1a - Phase 1Dose Level 2 - Phase 1Dose Level 3 - Phase 1Dose level 1 - Phase 1Dose level 1b - Phase 1Phase 2
XelodaDRUG

Twice a day orally on days 1 through 14 of a 21 day cycle

Also known as: Capecitabine
Dose Level 1a - Phase 1Dose Level 2 - Phase 1Dose Level 3 - Phase 1Dose level 1 - Phase 1Dose level 1b - Phase 1Phase 2
CisplatinDRUG

IV on days 4 and 11 of a 21 day cycle

Also known as: Platinol
Dose Level 1a - Phase 1Dose Level 2 - Phase 1Dose Level 3 - Phase 1Dose level 1 - Phase 1Dose level 1b - Phase 1Phase 2
IrinotecanDRUG

IV on days 4 and 11 of a 21 day cycle

Also known as: Camptosar
Dose Level 1a - Phase 1Dose Level 2 - Phase 1Dose Level 3 - Phase 1Dose level 1 - Phase 1Dose level 1b - Phase 1Phase 2

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
  • Have measurable disease.
  • Male or non-pregnant and non-lactating female of age \>18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
  • Subjects must have adequate organ and marrow function.
  • Must use acceptable form of birth control prior to study and and for the duration of study.
  • Willing and able to comply with study procedures

You may not qualify if:

  • 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, taxotere, xeloda, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • Christenson ES, Lim SJ, Durham J, De Jesus-Acosta A, Bever K, Laheru D, Ryan A, Agarwal P, Scharpf RB, Le DT, Wang H. Cell-free DNA Predicts Prolonged Response to Multi-agent Chemotherapy in Pancreatic Ductal Adenocarcinoma. Cancer Res Commun. 2022 Nov 11;2(11):1418-1425. doi: 10.1158/2767-9764.CRC-22-0343. eCollection 2022 Nov.

    PMID: 36970054DERIVED

MeSH Terms

Interventions

GemcitabineDocetaxelCapecitabineCisplatinIrinotecan

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloids

Results Point of Contact

Title
Dung Le, MD
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
dle@jhmi.edu
443-287-0002

Study Officials

  • Dung Le, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

February 1, 2015

Primary Completion

June 1, 2019

Study Completion

February 1, 2020

Last Updated

July 21, 2023

Results First Posted

September 14, 2020

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)