Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00068419
Recruitment Status : Active, not recruiting
First Posted : September 11, 2003
Results First Posted : December 4, 2013
Last Update Posted : April 21, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

September 10, 2003
September 11, 2003
October 7, 2013
December 4, 2013
April 21, 2017
February 2004
August 2010   (Final data collection date for primary outcome measure)
Event-free Survival [ Time Frame: Study enrollment until time of disease progression or death as a first event (maximum follow-up 5 years) ]
Two-year event-free survival (EFS). Events include disease progression (increase in the greatest product of 2 perpendicular diameters of any lesion by > 25% or new biopsy-proven lesions), and death in absence of disease progression. Reported as Kaplan-Meier estimate of two-year EFS proportion.
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Complete list of historical versions of study NCT00068419 on Archive Site
  • Toxicity as Assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0 [ Time Frame: Up to 12 months ]
  • Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ]
  • Changes in Magnetic Resonance Imaging (MRI) Signal Features [ Time Frame: From baseline to up to 5 years ]
    MRI must include images in at least two planes with (a) pre-contrast images with the following pulse sequences T-1 weighted, fast spin echo T-2 weighted with fat saturation, and a short tau inversion recovery (STIR); and (b) post-contrast images with T-1 weighted pulse sequence with fat suppression.
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Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy
This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. 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.


I. Determine the progression-free survival of patients with desmoid tumor that is recurrent or not amenable to standard therapy treated with sulindac and tamoxifen.

II. Determine the safety and efficacy of this regimen, in terms of event-free survival, of these patients.


I. Determine the tumor response rate in patients treated with this regimen.

II. Correlate changes in Magnetic Resonance Imaging (MRI) signal features of the tumor with clinical outcome in patients treated with this regimen.

III. 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.

IV. Collect information about clinical factors that make a tumor unresectable at diagnosis and resectable during the four courses of study treatment.

V. 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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Desmoid Tumor
  • Drug: tamoxifen citrate
    Given orally
    Other Names:
    • Nolvadex
    • TAM
    • tamoxifen
    • TMX
  • Drug: sulindac
    Given orally
    Other Names:
    • Aflodac
    • Algocetil
    • Clinoril
    • SULIN
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (enzyme inhibitor therapy, anti-estrogen therapy)
Patients receive oral sulindac and oral tamoxifen citrate 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.
  • Drug: tamoxifen citrate
  • Drug: sulindac
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
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August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Performance status - Karnofsky Score 50-100% (patients over age 16)
  • Performance status - Lansky Score 50-100% (patients age 16 and under)
  • At least 8 weeks
  • 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
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) less than 2.5 times ULN
  • 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])
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  • No prior deep venous thrombosis
  • Electrocardiogram (EKG) normal
  • Chest x-ray normal
  • No prior significant gastrointestinal hemorrhage
  • No prior peptic ulcer disease
  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception
  • No evidence of active graft-versus-host disease
  • No allergy to aspirin
  • 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
  • No prior nonsteroidal anti-inflammatory drugs (NSAIDs) for desmoid tumor
  • More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No concurrent anticancer chemotherapy
  • No prior estrogen antagonists for desmoid tumor
  • No concurrent hormonal contraceptives
  • No concurrent steroids except for non tumor indications (e.g., asthma or severe allergic reactions)
  • No concurrent NSAIDs for desmoid tumor

    • Occasional NSAIDs for musculoskeletal or other pain are allowed
  • Recovered from prior radiotherapy
  • No concurrent adjuvant radiotherapy
  • No concurrent participation in another COG therapeutic study
Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Australia,   Canada,   Netherlands,   New Zealand,   Puerto Rico,   Switzerland
NCI-2009-00424 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000322260 ( Other Identifier: PDQ (Physician Data Query) )
COG-ARST0321 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
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Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Stephen Skapek, MD Children's Oncology Group
Children's Oncology Group
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP