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Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
This study has been suspended.
First Received: September 10, 2003   Last Updated: July 2, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068419
  Purpose

RATIONALE: Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor.


Condition Intervention Phase
Desmoid Tumor
Drug: sulindac
Drug: tamoxifen citrate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate [ Designated as safety issue: No ]
  • Changes in MRI signal features of tumor with clinical outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: February 2004
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the progression-free survival of patients with desmoid tumor that is recurrent or not amenable to standard therapy treated with sulindac and tamoxifen.
  • Determine the safety and efficacy of this regimen, in terms of event-free survival, of these patients.

Secondary

  • Determine the tumor response rate in patients treated with this regimen.
  • Correlate changes in MRI signal features of the tumor with clinical outcome in patients treated with this regimen.
  • Correlate pathological studies of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression in the tumor with clinical outcome in patients treated with this regimen.
  • Collect information about clinical factors that make a tumor unresectable at diagnosis and resectable during the four courses of study treatment.
  • Determine whether short-term endocrine toxicity is associated with treatment with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sulindac and oral tamoxifen twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.

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

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 4.8 years.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed desmoid tumor, meeting 1 of the following criteria:

    • Newly diagnosed disease

      • Not previously treated
      • Not amenable to complete surgical resection and/or radiotherapy

        • If surgical resection was attempted, there must be gross residual disease measurable by MRI
    • Radiographically documented recurrent or progressive disease

      • No prior chemotherapy or radiotherapy for the present recurrence

        • Tumors that progressed on prior chemotherapy are allowed provided patients have not received chemotherapy for this recurrence
  • Measurable disease by gadolinium-enhanced MRI
  • No other fibroblastic lesions or fibromatoses

    • Lipofibromatosis or desmoplastic fibroma of the bone allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and under at original diagnosis

Performance status

  • Karnofsky 50-100% (patients over age 16) OR
  • Lansky 50-100% (patients age 16 and under)

Life expectancy

  • At least 8 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3 (transfusion independent)
  • Hemoglobin at least 10.0 g/dL (transfusion allowed)
  • No hemophilia
  • No von Willebrand disease
  • No other clinically significant bleeding diathesis

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT less than 2.5 times ULN

Renal

  • Creatinine adjusted according to age as follows:

    • No greater than 0.4 mg/dL (≤ 5 months)
    • No greater than 0.5 mg/dL (6 months -11 months)
    • No greater than 0.6 mg/dL (1 year-23 months)
    • No greater than 0.8 mg/dL (2 years-5 years)
    • No greater than 1.0 mg/dL (6 years-9 years)
    • No greater than 1.2 mg/dL (10 years-12 years)
    • No greater than 1.4 mg/dL (13 years and over [female])
    • No greater than 1.5 mg/dL (13 years to 15 years [male])
    • No greater than 1.7 mg/dL (16 years and over [male]) OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

  • No prior deep venous thrombosis
  • EKG normal

Pulmonary

  • Chest x-ray normal

Gastrointestinal

  • No prior significant gastrointestinal hemorrhage
  • No prior peptic ulcer disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception
  • No evidence of active graft-versus-host disease
  • No allergy to aspirin

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from prior immunotherapy
  • At least 7 days since prior anticancer biologic agents
  • At least 6 months since prior allogeneic stem cell transplantation
  • More than 1 week since prior growth factors
  • No concurrent immunomodulating agents

Chemotherapy

  • See Disease Characteristics
  • More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • No prior estrogen antagonists for desmoid tumor
  • No concurrent hormonal contraceptives
  • No concurrent steroids except for nontumor indications (e.g., asthma or severe allergic reactions)

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No concurrent adjuvant radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No prior nonsteroidal anti-inflammatory drugs (NSAIDs) for desmoid tumor
  • No concurrent NSAIDs for desmoid tumor

    • Occasional NSAIDs for musculoskeletal or other pain are allowed
  • No concurrent participation in another COG therapeutic study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068419

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Southern California Permanente Medical Group
Downey, California, United States, 90027
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Colorado
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-3730
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712-6297
United States, Illinois
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Simmons Cooper Cancer Institute
Springfield, Illinois, United States, 62794-9677
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199-0001
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308-1062
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2696
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404-1815
United States, Oregon
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada
Centre Hospitalier Universitaire de Quebec
Quebec, Canada, G1V 4G2
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
New Zealand
Starship Children's Health
Auckland, New Zealand, 1
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Steve Skapek, MD University of Chicago Comer Children's Hospital
Investigator: R. Beverly Raney, MD Driscoll Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group - Group Chair Office ( Gregory H. Reaman )
Study ID Numbers: CDR0000322260, COG-ARST0321
Study First Received: September 10, 2003
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00068419     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
desmoid tumor

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Fibroma
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms, Connective and Soft Tissue
Fibromatosis, Aggressive
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Estrogen Antagonists
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Tamoxifen
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Sulindac
Neoplasms, Connective Tissue
Peripheral Nervous System Agents
Neoplasms, Fibrous Tissue
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 22, 2009