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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
For Condition: stage 2 pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer
Status: No longer recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer.
Details: OBJECTIVES: - Compare the 1-year survival rate in patients with locally advanced pancreatic cancer treated with paclitaxel, gemcitabine, and radiotherapy with or without tipifarnib. - Determine the toxicity and loco-regional activity of this chemoradiotherapy regimen in these patients. - Determine the feasibility and toxicity of prolonged administration of tipifarnib after chemoradiotherapy in these patients. - Determine whether tipifarnib administered after chemoradiotherapy can increase progression-free and overall survival in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the preceding 6 months (more than 10% vs 10% or less) and tumor dimension (at least 5 cm vs less than 5 cm). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive radiotherapy once daily, 5 days a week, for 5.5 weeks, beginning on day 1. Patients also receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. - Arm II: Patients receive chemoradiotherapy as in arm I. Within 3-8 weeks after completion of chemoradiotherapy, patients without disease progression receive oral tipifarnib twice daily for 21 days. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 154 patients (77 per treatment arm) will be accrued for this study within approximately 20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas - Residual disease after resection (R1 or R2, microscopic or macroscopic) allowed - No metastases in major viscera - No peritoneal seeding or ascites - Biliary or gastroduodenal obstruction must have drainage before starting study therapy - Radiographically assessable disease encompassable within a single irradiation field (15 by 15 cm maximum) PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,800/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - ALT less than 3 times upper limit of normal - Bilirubin less than 2.0 mg/dL Renal: - Creatinine less than 3.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 2 years except non-melanoma skin cancer or carcinoma in situ of the cervix, uterus, or bladder - No significant infection or other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy (including gemcitabine or paclitaxel) for pancreatic cancer - No other concurrent cytotoxic agents Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to the planned field - No other concurrent radiotherapy Surgery: - See Disease Characteristics Other: - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TyvinRich, Study Chair, University of Virginia, Health Sciences Center Cancer Center
Cape Cod Hospital
Hyannis, Massachusetts, 02601
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, 19023
United States
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, 68114
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0385
United States
St. John Macomb Hospital
Warren, Michigan, 48093-3494
United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Yakima Valley Memorial Hospital
Yakima, Washington, 98902
United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051
United States
Mills-Peninsula Health Services
Burlingame, California, 94010
United States
Baptist Hospital of Miami
Miami, Florida, 33256-2110
United States
St. Joseph Mercy Hospital
Pontiac, Michigan, 48341-2985
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Akron General Medical Center
Akron, Ohio, 44302
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54301
United States
Akron City Hospital
Akron, Ohio, 44304
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439-8066
United States
Richland Memorial Hospital
Olney, Illinois, 62450
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70821-2511
United States
McKay-Dee Hospital Center
Ogden, Utah, 84403
United States
Union Hospital
Terre Haute, Indiana, 47804
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Margaret Pardee Memorial Hospital
Hendersonville, North Carolina, 28791
United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
United States
Lankenau Cancer Center
Wynnewood, Pennsylvania, 19096
United States
All Saints Cancer Center
Racine, Wisconsin, 53405
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
United States
Greenville Hospital System
Greenville, South Carolina, 29605
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
United States
St. John Health System
Tulsa, Oklahoma, 74104
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Dixie Regional Medical Center
St. George, Utah, 84770
United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904
United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
United States
Deaconess Medical Center
Spokane, Washington, 99204
United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
United States
Atlantic City Medical Center
Pomona, New Jersey, 08240
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
United States
Medical Center of Louisiana at New Orleans
New Orleans, Louisiana, 70140-1015
United States
Saint Joseph Mercy Hospital
Ypsilanti, Michigan, 48197
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Seton Cancer Institute - West Branch
West Branch, Michigan, 48661
United States
Danville Regional Medical Center
Danville, Virginia, 24541
United States
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, 27533
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Additional Information:
Study ID Numbers: CDR0000068986; RTOG-PA-0020,RTOG-DEV-1003
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026104
Other Adenocarcinoma Of The Pancreas Studies:
1. Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
2. Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
3. Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer
4. Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
5. Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer
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