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

Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02324543
Enrollment
47
Registered
2014-12-24
Start date
2015-02-28
Completion date
2020-02-29
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Adenocarcinoma

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.

Detailed description

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.

Interventions

DRUGGemcitabine

IV on days 4 and 11 of a 21 day cycle

DRUGTaxotere

IV on days 4 and 11 of a 21 day cycle

DRUGXeloda

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

DRUGCisplatin

IV on days 4 and 11 of a 21 day cycle

DRUGIrinotecan

IV on days 4 and 11 of a 21 day cycle

Sponsors

Swim Across America
CollaboratorOTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival (OS) Rate at 9 Months9 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)
Maximum Tolerated Dose (MTD) of Docetaxel28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Maximum Tolerated Dose (MTD) of Capecitabine28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use.
Maximum Tolerated Dose (MTD) of Cisplatin28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Maximum Tolerated Dose (MTD) of Irinotecan28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Maximum Tolerated Dose (MTD) of Gemcitabine28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.

Secondary

MeasureTime frameDescription
Disease Control Rate (DCR) Using RECIST 1.1 Criteria43 monthsDCR 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.
Progression-free Survival (PFS) Using RECIST 1.1 Criteria5 yearsPFS 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.
Overall Survival (OS)5 yearsOS 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.
Response Rate (RR) Using RECIST 1.1 Criteria43 monthsRR 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Dose Level 1 - Phase 1
Gemcitabine: 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
6
Dose Level 1a - Phase 1
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
6
Dose Level 1b - Phase 1
Gemcitabine - 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
3
Dose Level 2 - Phase 1
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin -15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
4
Dose Level 3 - Phase 1
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin - 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Irinotecan - 60 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
4
Phase 2
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
24
Total47

Baseline characteristics

CharacteristicTotalDose Level 1 - Phase 1Dose Level 1a - Phase 1Dose Level 1b - Phase 1Dose Level 2 - Phase 1Dose Level 3 - Phase 1Phase 2
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
21 Participants3 Participants4 Participants1 Participants0 Participants2 Participants11 Participants
Age, Categorical
Between 18 and 65 years
26 Participants3 Participants2 Participants2 Participants4 Participants2 Participants13 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants6 Participants6 Participants3 Participants4 Participants4 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants0 Participants1 Participants0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
40 Participants6 Participants4 Participants3 Participants2 Participants3 Participants22 Participants
Sex: Female, Male
Female
20 Participants4 Participants3 Participants1 Participants1 Participants3 Participants8 Participants
Sex: Female, Male
Male
27 Participants2 Participants3 Participants2 Participants3 Participants1 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
2 / 61 / 60 / 30 / 40 / 40 / 24
other
Total, other adverse events
6 / 66 / 63 / 34 / 44 / 424 / 24
serious
Total, serious adverse events
0 / 61 / 61 / 32 / 41 / 42 / 24

Outcome results

Primary

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.

Time frame: 28 days

ArmMeasureValue (NUMBER)
Phase 1Maximum Tolerated Dose (MTD) of Capecitabine500 mg
Primary

Maximum Tolerated Dose (MTD) of Cisplatin

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

Time frame: 28 days

ArmMeasureValue (NUMBER)
Phase 1Maximum Tolerated Dose (MTD) of Cisplatin20 mg/m^2
Primary

Maximum Tolerated Dose (MTD) of Docetaxel

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

Time frame: 28 days

ArmMeasureValue (NUMBER)
Phase 1Maximum Tolerated Dose (MTD) of Docetaxel20 mg/m^2
Primary

Maximum Tolerated Dose (MTD) of Gemcitabine

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

Time frame: 28 days

ArmMeasureValue (NUMBER)
Phase 1Maximum Tolerated Dose (MTD) of Gemcitabine500 mg/m^2
Primary

Maximum Tolerated Dose (MTD) of Irinotecan

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

Time frame: 28 days

ArmMeasureValue (NUMBER)
Phase 1Maximum Tolerated Dose (MTD) of Irinotecan20 mg/m^2
Primary

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)

Time frame: 9 months

Population: This measure was only assessed for Phase 2. Per protocol, the 6 subjects treated at the MTD (DL1a) during dose escalation (Phase 1) were counted toward the total sample size of 30 subjects for the Phase 2 outcome measure.

ArmMeasureValue (NUMBER)
Phase 1Overall Survival (OS) Rate at 9 Months57 percentage of participants
Secondary

Disease Control Rate (DCR) Using RECIST 1.1 Criteria

DCR 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.

Time frame: 43 months

ArmMeasureValue (NUMBER)
Phase 1Disease Control Rate (DCR) Using RECIST 1.1 Criteria87 percentage of participants
Secondary

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.

Time frame: 5 years

ArmMeasureValue (MEDIAN)
Phase 1Overall Survival (OS)11.02 Months
Secondary

Progression-free Survival (PFS) Using RECIST 1.1 Criteria

PFS 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.

Time frame: 5 years

ArmMeasureValue (MEDIAN)
Phase 1Progression-free Survival (PFS) Using RECIST 1.1 Criteria8.34 Months
Secondary

Response Rate (RR) Using RECIST 1.1 Criteria

RR 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.

Time frame: 43 months

ArmMeasureValue (NUMBER)
Phase 1Response Rate (RR) Using RECIST 1.1 Criteria57 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026