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A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03535727
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Adenocarcinoma Pancreatic Neoplasms Neoplasm, Glandular Neoplasms Neoplasms Pancreatic Digestive System Neoplasm Endocrine Gland Neoplasms Digestive System Disease Pancreatic Diseases Endocrine System Diseases Drug: Nab-paclitaxel Drug: Gemcitabine Drug: Capecitabine Drug: Cisplatin Drug: Irinotecan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021


Arm Intervention/treatment
Experimental: Cohort 1
(28 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan
Drug: Nab-paclitaxel
IV over 30 minutes; Days 1 and 15
Other Name: Abraxane

Drug: Gemcitabine
IV over 30 minutes; Days 1 and 15
Other Name: Gemzar

Drug: Capecitabine
PO twice daily (BID); Days 1-7, 15-21
Other Name: Xeloda

Drug: Cisplatin
IV over 60 minutes; Days 1 and 15
Other Name: Platinol

Drug: Irinotecan
IV over 30 minutes; Days 1 and 15
Other Name: Camptosar

Experimental: Cohort 2
(21 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan
Drug: Nab-paclitaxel
IV over 30 minutes; Days 4 and 11
Other Name: Abraxane

Drug: Gemcitabine
IV over 30 minutes; Days 4 and 11
Other Name: Gemzar

Drug: Capecitabine
PO BID; Days 1- 14
Other Name: Xeloda

Drug: Cisplatin
IV over 60 minutes; Days 4 and 11
Other Name: Platinol

Drug: Irinotecan
IV over 30 minutes; Days 4 and 11
Other Name: Camptosar




Primary Outcome Measures :
  1. Part 1: Percentage of participants experiencing toxicities [ Time Frame: 4 years ]
    Percentage of participants by grade of toxicity as defined by CTCAE version 5.

  2. Part 2: Progression Free Survival (PFS) [ Time Frame: 4 years ]
    Duration of time (months) from start of treatment to time of first documented progression or death, whichever occurs first.


Secondary Outcome Measures :
  1. Part 2: Response Rate (RR) [ Time Frame: 4 years ]
    Percentage of patients who achieved complete response (CR) or partial response (PR) among all evaluable patients.

  2. Part 2: Disease Control Rate (DCR) [ Time Frame: 4 years ]
    Percentage of patients who achieved complete response (CR), partial response (PR), or stable disease (SD) among all evaluable patients.

  3. Part 2: Overall survival (OS) [ Time Frame: 4 years ]
    Duration of time (months) from start of treatment to time of death.

  4. Part 2: Percentage of participants experiencing toxicities with GAX-CI (gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan, a combinatorial therapy). [ Time Frame: 4 years ]
    Percentage of participants by grade of toxicity as defined by CTCAE version 5.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
  • Patients with the presence of at least one measurable lesion.
  • Male or non-pregnant and non-lactating female of age >18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
  • Must use acceptable form of birth control while on study.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who will be considered for surgery are ineligible.
  • 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, nab-paclitaxel, capecitabine, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535727


Contacts
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Contact: Susan Sartorius-Mergenthaler, RN 410-614-3644 Sartosu@jhmi.edu
Contact: Jane Zorzi, RN 410-614-5818 Jzorzi1@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Susan Sartorius-Mergenthaler, RN    410-614-3644    Sartosu@jhmi.edu   
Contact: Jane Zorzi, RN    410-614-5818    Jzorzi1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Dung Le, MD Johns Hopkins Medical Institution

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03535727     History of Changes
Other Study ID Numbers: J1847
IRB00167664 ( Other Identifier: Johns Hopkins Medical Institution )
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Gastrointestinal Diseases
Pancreatic Diseases
Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Capecitabine
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents