Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer

February 1, 2019 updated by: University of Texas Southwestern Medical Center

Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic body radiation therapy together with gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of stereotactic body radiation therapy when given with or without gemcitabine hydrochloride in treating patients with pancreatic cancer that can be removed by surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To demonstrate the feasibility and safety of administering margin-intensive stereotactic body radiotherapy together with preoperative gemcitabine hydrochloride to patients with resectable pancreatic adenocarcinoma.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine hydrochloride. Patients receive 1 of 2 treatment regimens.

  • Regimen 1: Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
  • Regimen 2: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.

After completion of study treatment, patients are followed periodically for 5 years.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Pathologically confirmed localized adenocarcinoma of the pancreas or distal common bile duct

    • Pancreatic ductal adenocarcinoma or peripancreatic cholangiocarcinoma

  • Resectable disease, as determined by the Gastrointestinal Cancer Working Group disease-oriented team

    • Criteria used to define unresectability will include, but not be limited to, the following:

      • Tumor encases > 180 degrees of the circumference of the superior mesenteric artery
      • Tumor encases the common hepatic artery with no anatomic option for reconstruction following segmental resection
      • Superior mesenteric vein occluded or encased with no option for reconstruction following segmental resection
      • Soft tissue infiltration of the retroperitoneum to the left of the superior mesenteric artery
  • All malignant disease must be encompassed within a single radiotherapy field
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute granulocyte count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Creatinine clearance > 50mL/min
  • AST and ALT < 5 times upper limit of normal
  • Serum bilirubin < 5 mg/dL (with biliary decompression)
  • INR ≤ 1.5
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Medically fit for pancreatic surgical resection, as determined by the investigating surgeons at the time of study enrollment
  • No evidence of an active second invasive malignancy outside the area of the pancreas or biliary system within the past 2 years, except for non-melanomatous skin cancer or carcinoma in situ of the breast, bladder, cervix, or uterus

  • No clinically significant cardiac disease, including the following:

    • Uncontrolled hypertension, defined as blood pressure > 160/90 mm Hg on medication
    • Myocardial infarction within the past 6 months
    • NYHA class II-IV congestive heart failure

    • Unstable symptomatic arrhythmia requiring medication (e.g., chronic atrial arrhythmia [atrial fibrillation or paroxysmal supraventricular tachycardia])

      • Atrial arrhythmia allowed provided it is well-controlled on stable medication
    • No current or recent (within the past 6 months) unstable angina
  • No recent (within the past 6 months) arterial thromboembolic events, including transient ischemic attack, cerebrovascular accident, or clinically significant peripheral artery disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • No serious nonhealing wound, ulcer, or currently healing fracture
  • No AIDS
  • No significant infection or other coexisting medical condition that would preclude study therapy
  • No gastrointestinal fistula or perforation within the past 10 years

PRIOR CONCURRENT THERAPY:

  • More than 2 years since prior chemotherapy (other than for pancreaticobiliary cancer)
  • More than 28 days since prior major surgical procedure or open biopsy
  • No prior intraabdominal radiotherapy in the planned field of pancreatic margin-intensive radiotherapy
  • No prior organ transplantation
  • No concurrent major surgical procedure
  • No other concurrent cytotoxic chemotherapy or anti-neoplastic biologic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen 1
Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
Radiation: stereotactic body radiation therapy
Given as a single fraction
Experimental: Regimen 2
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Patients undergo a single fraction of SBRT between days 21-28 followed by pancreatoduodenectomy between days 35-63.
Drug: gemcitabine hydrochloride
Given IV
Radiation: stereotactic body radiation therapy
Given as a single fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection
Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery
Total dose of chemotherapy and radiotherapy delivered
Pre-treatment and post-treatment characteristics of the primary tumor on preoperative axial imaging including, but not limited to, tumor size, percentage of encasement/abutment of mesenteric vessels, and progression of disease
Postoperative complications including, but not limited to, need for reoperation, need for interventional radiology fluid collection drainage, systemic infection, wound infection, prolonged ICU stay, and delayed gastric emptying
Operative drain amylase at days 3 and 5 postoperatively
Length of hospital stay following pancreatic resection
Degree of histologic response of tumor in the resected specimen
Tumor samples for RNA and protein harvesting (when possible) from pretreatment biopsies and surgical specimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: John C. Mansour, MD, Simmons Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 18, 2011

Study Completion (Actual)

February 18, 2011

Study Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCC-01209
  • CDR0000657523 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-2011-01117 (Registry Identifier: CTRP (Clinical Trials Reporting System))

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on gemcitabine hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe