Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00026104

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: tipifarnib Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Randomized Phase II Trial Of Weekly Gemcitabine, Paclitaxel And External Irradiation (50.4GY) Followed By The Farnesyl Transferase Inhibitor R115777 (NSC # 702818) For Locally Advanced Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride R 115777 Tipifarnib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2001

Detailed Description:

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026104

Hide Study Locations

Locations

United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Mills-Peninsula Health Services
Burlingame, California, United States, 94010
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
United States, Colorado
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States, 30165
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Richland Memorial Hospital
Olney, Illinois, United States, 62450
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Indiana
Union Hospital
Terre Haute, Indiana, United States, 47804
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70821-2511
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Medical Center of Louisiana at New Orleans
New Orleans, Louisiana, United States, 70140-1015
United States, Maryland
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
United States, Michigan
St. Joseph Mercy Hospital
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
Seton Cancer Institute - West Branch
West Branch, Michigan, United States, 48661
St. John Macomb Hospital
Warren, Michigan, United States, 48093-3494
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439-8066
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Nebraska
Methodist Hospital Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Community Medical Center
Toms River, New Jersey, United States, 08755
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States, 08060
Atlantic City Medical Center
Pomona, New Jersey, United States, 08240
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, North Carolina
Margaret Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, United States, 27533
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44302
CCOP - Dayton
Dayton, Ohio, United States, 45429
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oklahoma
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
St. John Health System
Tulsa, Oklahoma, United States, 74104
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lankenau Cancer Center
Wynnewood, Pennsylvania, United States, 19096
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States, 19023
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Texas
Harrington Cancer Center
Amarillo, Texas, United States, 79106
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Deaconess Medical Center
Spokane, Washington, United States, 99204
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, Wisconsin
All Saints Cancer Center
Racine, Wisconsin, United States, 53405
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Tyvin A. Rich, MD

University of Virginia

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Rich TA, Myerson RJ, Harris J, et al.: A randomized phase II trial of weekly gemcitabine (G), paclitaxel (P), and external irradiation followed by the farnesyl transferase inhibitor R115777 (NSC#702818) for locally advanced pancreatic cancer (RTOG 0020). [Abstract] American Society of Clinical Oncology 2006 Gastrointestinal Cancers Symposium, 26-28 January 2006, San Francisco, California. A-121, 2006.

Garofalo MC, Winter K, Regine WF, et al.: Recursive partitioning analysis (RPA) of prognostic factors in six Radiation Therapy Oncology Group (RTOG) trials of chemoradiotherapy for unresectable pancreatic cancer. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-144, S80-1, 2006.

Study ID Numbers:	CDR0000068986, RTOG-PA-0020, RTOG-DEV-1003
Study First Received:	November 9, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00026104 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Tipifarnib
Endocrine Gland Neoplasms
Digestive System Neoplasms

Mitosis Modulators
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Pancreatic Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 25, 2009