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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
stereotactic body radiation therapy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Regimen 1

Regimen 2

Arm Description

Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2009
Last Updated
February 1, 2019
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01025882
Brief Title
Margin-Intense Combo Therapy in Pts w/Potentially Resectable Pancreatic Cancer
Official Title
Phase I Study of Margin-Intense Combination Therapy for Patients With Potentially Resectable Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
DSMC closed due to patient deaths
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 18, 2011 (Actual)
Study Completion Date
February 18, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen 1
Arm Type
Experimental
Arm Description
Patients undergo a single fraction of margin-intensive stereotactic body radiotherapy (SBRT) on day 1. Patients undergo pancreatoduodenectomy between days 15-43.
Arm Title
Regimen 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiation therapy
Intervention Description
Given as a single fraction
Primary Outcome Measure Information:
Title
Preoperative treatment-related toxicity, defined as adverse events occurring prior to surgical resection
Title
Postoperative surgical morbidity, defined as all other adverse events occurring within 90 days of surgery
Title
Total dose of chemotherapy and radiotherapy delivered
Title
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
Title
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
Title
Operative drain amylase at days 3 and 5 postoperatively
Title
Length of hospital stay following pancreatic resection
Title
Degree of histologic response of tumor in the resected specimen
Title
Tumor samples for RNA and protein harvesting (when possible) from pretreatment biopsies and surgical specimens

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Mansour, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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