Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Temporarily closed	18 and under at original diagnosis	NCI	COG-ARST0321 NCT00068419, ARST0321

Objectives

Primary

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

Secondary

1. Determine the tumor response rate in patients treated with this regimen.
2. Correlate changes in MRI signal features of the tumor with clinical outcome in patients treated with this regimen.
3. 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.
4. Collect information about clinical factors that make a tumor unresectable at diagnosis and resectable during the four courses of study treatment.
5. Determine whether short-term endocrine toxicity is associated with treatment with this regimen in these patients.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³ (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

Expected Enrollment

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

Outcomes

Event-free survival

Tumor response rate
Changes in MRI signal features of tumor with clinical outcomes

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Steve Skapek, MD, Protocol chair		Ph: 773-834-3508901; 800-289-6333
R. Beverly Raney, MD, Protocol co-chair(Contact information may not be current)		Ph: 361-694-5766; 800-324-5683

Registry Information
Official Title		A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy
Trial Start Date		2004-02-16
Trial Completion Date		2009-10-05 (estimated)
Registered in ClinicalTrials.gov		NCT00068419
Date Submitted to PDQ		2003-07-18
Information Last Verified		2009-07-28
NCI Grant/Contract Number		CA98543

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