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

NCT ID: NCT02324543

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2020-02-29

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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Taxotere

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Xeloda

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Irinotecan

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Taxotere

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Xeloda

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Irinotecan

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Taxotere

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Xeloda

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Irinotecan

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Taxotere

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Xeloda

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Irinotecan

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Taxotere

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Xeloda

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Irinotecan

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Taxotere

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Xeloda

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Irinotecan

Intervention Type: DRUG

IV on days 4 and 11 of a 21 day cycle

Interventions

Gemcitabine

IV on days 4 and 11 of a 21 day cycle

Intervention Type: DRUG

Taxotere

IV on days 4 and 11 of a 21 day cycle

Intervention Type: DRUG

Xeloda

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

Intervention Type: DRUG

Cisplatin

IV on days 4 and 11 of a 21 day cycle

Intervention Type: DRUG

Irinotecan

IV on days 4 and 11 of a 21 day cycle

Intervention Type: DRUG

Other Intervention Names

Gemzar; Docetaxel; Capecitabine; Platinol; Camptosar

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swim Across America

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dung Le, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36970054 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

J14161

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00053208

Identifier Type: OTHER

Identifier Source: secondary_id

J14161

Identifier Type: -

Identifier Source: org_study_id