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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT02324543
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    IV on days 4 and 11 of a 21 day cycle
  • Taxotere — DRUG
    IV on days 4 and 11 of a 21 day cycle
  • Xeloda — DRUG
    Twice a day orally on days 1 through 14 of a 21 day cycle
  • Cisplatin — DRUG
    IV on days 4 and 11 of a 21 day cycle
  • Irinotecan — DRUG
    IV on days 4 and 11 of a 21 day cycle

Study Details

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.

Key Dates

Start date
Feb 28, 2015
Status verified
Jul 2023
Primary completion
Jun 30, 2019
Completion
Feb 29, 2020

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Gemcitabine [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-

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