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Trial record 1 of 1 for:    NCT02283372
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Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced and Borderline Resectable Pancreatic Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02283372
First received: October 24, 2014
Last updated: July 17, 2017
Last verified: July 2017
  Purpose
A phase I study to evaluate safety of gemcitabine with nab-paclitaxel and concurrent IMRT for locally advanced and borderline resectable pancreatic cancer. The goal of this study is to evaluate if a chemotherapy regimen that provides superior systemic efficacy may be safely delivered and enhance efficacy of tumor directed radiation therapy.

Condition Intervention Phase
Pancreatic Cancer Drug: nab-Paclitaxel Drug: Gemcitabine Radiation: Intensity modulated radiation Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Prospective Phase I Study of Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: Completion of toxicity follow-up for all patients (up to 32 months) ]
    For the toxicity endpoint purposes of this trial, the patient will be followed from start of treatment until the patient completes 60 days of follow-up from the start of radiation therapy, has a dose-limiting toxicity (DLT), or is lost to follow-up.


Secondary Outcome Measures:
  • Rate of conversion of patients with locally advanced pancreatic cancer or borderline resectable to resectable [ Time Frame: 1 year ]
  • Local control (Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [ Time Frame: 1 year ]

    Local control is absence of tumor progression.

    Response and progression will be evaluated in this study using the new international criteria proposed by the revised

    Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).


  • Progression-free survival (PFS) [ Time Frame: 1 year ]
  • Overall survival (OS) [ Time Frame: 1 year ]
  • Quality of life [ Time Frame: 3 months after completion of treatment (up to 18 weeks) ]
    The EORTC QLQ-C30 questionnaire will be utilized.

  • Frequency of RT adaptation based on MR guidance [ Time Frame: 3 months after completion of treatment (up to 18 weeks) ]
    The rate at which a change or adaptation to the patient's plan is made based on significant change in anatomy observed on localization MRI. This is defined as [#of treatment adaptations required]/[total # of RT treatments]


Estimated Enrollment: 24
Actual Study Start Date: January 21, 2015
Estimated Study Completion Date: July 30, 2018
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nab-Paclitaxel + Gemcitabine + IMRT
  • Prior to initiation of chemoradiation, patients will undergo 1 full cycle of gemcitabine and nab-paclitaxel on Days 1, 8, and 15 of a 28-day cycle.
  • Both gemcitabine and nab-paclitaxel will be given intravenously on an outpatient basis during the one-month lead-in period and during Weeks 1 and 2 (and, if enrolled to Dose Level or 2, Weeks 4 and 5) of radiotherapy. There may be up to 21 days between the last dose of lead-in chemotherapy (given on Day 15) and initiation of chemoradiation (inclusive of the week following Day 15, the fourth week of the lead-in cycle (an off-week), and an additional week following that).
  • Intensity modulated radiation (IMRT) - the prescribed dose will range from 40-67.5 Gy over 15 to 25 fractions.
Drug: nab-Paclitaxel
Other Names:
  • Abraxane
  • Albumin-bound paclitaxel
Drug: Gemcitabine
Other Name: Gemzar®
Radiation: Intensity modulated radiation
Other Name: IMRT

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable based on institutional standardized criteria of unresectability or medical inoperability. Patients with and without regional adenopathy are eligible.
  • Prior systemic chemotherapy allowed. It is anticipated and suggested that most patients enrolled on study will have received a minimum of approximately 2 months of systemic therapy according to routine institutional practices. The patient must also be felt by the treating medical oncologist and radiation oncologist to be a candidate for treatment with gemcitabine/nab-paclitaxel chemoradiotherapy.
  • At least 18 years of age.
  • ECOG performance status ≤ 1
  • Normal bone marrow and organ function as defined below:

    • Absolute neutrophil count ≥ 1,000/mcl
    • Platelets ≥ 100,000/mcl
    • Hemoglobin ≥ 9.0 g/dL
    • Total bilirubin ≤ 1.5 x ULN
    • AST(SGOT)/ALT(SGPT) ≤ 1.5 x IULN
    • Serum creatinine ≤ 1.5 mg/dL or calculated CrCL>60mL/min using Cockcroft and Gault formula
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Distant metastatic disease, including known brain metastases.
  • History of prior malignancy is acceptable, but prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields is not allowed.
  • Currently receiving any other investigational agents.
  • Major surgery within 4 weeks prior to first study drug administration.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in the study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.
  • Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with gemcitabine and nab-paclitaxel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02283372

Contacts
Contact: Parag Parikh, M.D. (314) 747-9614 parikh@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Parag R Parikh, M.D.    314-747-9614    parikh@wustl.edu   
Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.         
Sub-Investigator: Manik Amin, M.D.         
Sub-Investigator: Maria Q Baggstrom, M.D.         
Sub-Investigator: Ryan C Fields, M.D.         
Sub-Investigator: William Hawkins, M.D.         
Sub-Investigator: Eric Knoche, M.D.         
Sub-Investigator: Kian-Huat Lim, M.D., Ph.D.         
Principal Investigator: Parag Parikh, M.D.         
Sub-Investigator: Steven M Strasberg, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Benjamin R Tan, M.D.         
Sub-Investigator: Jeff Michalski, M.D.         
Sub-Investigator: Stephanie Perkins, M.D.         
Sub-Investigator: Clifford Robinson, M.D.         
Sub-Investigator: Irman Zoberi, M.D.         
Sub-Investigator: Jeff Bradley, M.D.         
Sub-Investigator: Jiayi Huang, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02283372     History of Changes
Other Study ID Numbers: 201412038
Study First Received: October 24, 2014
Last Updated: July 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
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
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2017