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Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

2015-02

2019-06

2020-02

47

Study Overview

Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

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.

The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin. After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.

  • Metastatic Pancreatic Adenocarcinoma
  • DRUG: Gemcitabine
  • DRUG: Taxotere
  • DRUG: Xeloda
  • DRUG: Cisplatin
  • DRUG: Irinotecan
  • J14161
  • J14161 (OTHER Identifier) (OTHER: Swim Across America Laboratory)
  • IRB00053208 (OTHER Identifier) (OTHER: JHMIRB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2014-12-19  

2020-06-24  

2023-07-17  

2014-12-19  

2020-08-24  

2023-07-21  

2014-12-24  

2020-09-14  

2023-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dose level 1 - Phase 1

* 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: Gemcitabine

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Taxotere

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Xeloda

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

DRUG: Cisplatin

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Irinotecan

  • IV on days 4 and 11 of a 21 day cycle
EXPERIMENTAL: Dose Level 2 - Phase 1

* 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: Gemcitabine

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Taxotere

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Xeloda

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

DRUG: Cisplatin

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Irinotecan

  • IV on days 4 and 11 of a 21 day cycle
EXPERIMENTAL: Dose Level 3 - Phase 1

* 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: Gemcitabine

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Taxotere

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Xeloda

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

DRUG: Cisplatin

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Irinotecan

  • IV on days 4 and 11 of a 21 day cycle
EXPERIMENTAL: Dose Level 1a - Phase 1

* 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: Gemcitabine

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Taxotere

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Xeloda

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

DRUG: Cisplatin

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Irinotecan

  • IV on days 4 and 11 of a 21 day cycle
EXPERIMENTAL: Dose level 1b - Phase 1

* 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: Gemcitabine

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Taxotere

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Xeloda

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

DRUG: Cisplatin

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Irinotecan

  • IV on days 4 and 11 of a 21 day cycle
EXPERIMENTAL: Phase 2

* 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: Gemcitabine

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Taxotere

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Xeloda

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

DRUG: Cisplatin

  • IV on days 4 and 11 of a 21 day cycle

DRUG: Irinotecan

  • IV on days 4 and 11 of a 21 day cycle
Primary Outcome MeasuresMeasure DescriptionTime Frame
Maximum Tolerated Dose (MTD) of GemcitabineDose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.28 days
Maximum Tolerated Dose (MTD) of DocetaxelDose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.28 days
Maximum Tolerated Dose (MTD) of CapecitabineDose 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 CisplatinDose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.28 days
Maximum Tolerated Dose (MTD) of IrinotecanDose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2.28 days
Overall Survival (OS) Rate at 9 MonthsOS 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 Outcome MeasuresMeasure DescriptionTime Frame
Response Rate (RR) Using RECIST 1.1 CriteriaRR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.43 months
Disease Control Rate (DCR) Using RECIST 1.1 CriteriaDCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.43 months
Progression-free Survival (PFS) Using RECIST 1.1 CriteriaPFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.5 years
Overall Survival (OS)OS will be measured (in months) from date of first dose until death or end of follow-up (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.5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma. 2. Have measurable disease. 3. Male or non-pregnant and non-lactating female of age >18 years. 4. 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 5. Subjects must have adequate organ and marrow function. 6. Must use acceptable form of birth control prior to study and and for the duration of study. 7. Willing and able to comply with study procedures
    Exclusion Criteria:
    1. Patient who have had any prior chemotherapy within 5 years of enrollment. 2. Patient who have had radiotherapy for pancreatic cancer. 3. Age ≥ 76 years 4. Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study. 5. Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study. 6. Patient who has known brain metastases. 7. Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan. 8. 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 9. Patient who has serious medical risk factors involving any of the major organ systems. 10. Patient who has known history of infection with HIV, hepatitis B, or hepatitis C. 11. Pregnant or breast feeding. 12. Patient is unwilling or unable to comply with study procedures 13. Patient with clinically significant wound

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Swim Across America
  • PRINCIPAL_INVESTIGATOR: Dung Le, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
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