A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients With Locally Advanced Unresected Pancreatic Adenocarcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer
Both
Pancreatic Cancer
Trial Information
A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients With Locally Advanced Unresected Pancreatic Adenocarcinoma
OBJECTIVES: I. Assess the one year overall survival rate of patients with advanced,
unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and
dipyridamole. II. Assess the response rate in this group of patients. III. Evaluate the
frequency and severity of the toxic effects associated with this therapy. IV. Assess the
rate of resectability in patients who respond to therapy.
OUTLINE: All patients undergo surgical placement of an indwelling central venous line.
Patients receive fluorouracil IV by continuous infusion on days 1-28, leucovorin calcium IV
on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin IV every 6 weeks
starting on day 1. Treatment repeats every 6 weeks for 4 courses. Patients with a partial or
complete response are reevaluated for possible surgical resection. Resected patients resume
chemotherapy 4-8 weeks after surgery for an additional 16 weeks. Patients are followed every
6 months for 2 years, then annually until death.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage II or III pancreatic
adenocarcinoma Ductal adenocarcinoma Mucinous noncystic carcinoma Signet ring cell
carcinoma Adenosquamous carcinoma Undifferentiated (anaplastic) carcinoma Mixed
ductal-endocrine carcinoma Well differentiated adenocarcinoma Moderately well or poorly
differentiated adenocarcinoma Undifferentiated ductal carcinoma Must have unresectable and
localized disease Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: Not pregnant or nursing Fertile patients must use effective contraception Loss of
no greater than 15% of actual body weight Oral intake of greater than 1,200 calories per
day No other malignancy within the past 5 years except adequately treated basal or
squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer
that is currently in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic
chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior
radiation therapy for pancreatic cancer Surgery: At least 2 weeks since prior surgical
bypass procedure and recovered
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
One year
Safety Issue:
No
Principal Investigator
William H. Isacoff, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000065599
NCT ID:
NCT00003018
Start Date:
September 1997
Completion Date:
January 2007
Related Keywords:
- Pancreatic Cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- duct cell adenocarcinoma of the pancreas
- Adenocarcinoma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| MBCCOP - University of South Alabama | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Dwight David Eisenhower Army Medical Center | Fort Gordon, Georgia 30905-5650 |
| Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines, Illinois 60141 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Wichita | Wichita, Kansas 67218 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Providence Hospital - Southfield | Southfield, Michigan 48075-9975 |
| Veterans Affairs Medical Center - Biloxi | Biloxi, Mississippi 39531-2410 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Oklahoma City | Oklahoma City, Oklahoma 73104 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Texas Tech University Health Science Center | Lubbock, Texas 79415 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Veterans Affairs Medical Center - Phoenix (Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
| Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
