A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy
N/A
18 Years
Both
Desmoid Tumor
Trial Information
A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. Determine the tumor response rate in patients treated with this regimen. II. Correlate
changes in 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.
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 50-100% (patients over age 16)
- Performance status - Lansky 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)
- 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
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free survival
Outcome Description:
The method of Woolson will be used and one sample log-rank test will be applied to compare the event free survival on this study to the fixed expected outcome, F0 (t). Monitoring will be accomplished using an O'Brien and Fleming boundary, truncated at 3 standard deviations.
Outcome Time Frame:
Up to 2 years
Safety Issue:
No
Principal Investigator
Stephen Skapek
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
ARST0321
NCT ID:
NCT00068419
Start Date:
February 2004
Completion Date:
Related Keywords:
- Desmoid Tumor
- Fibromatosis, Aggressive
Name | Location |
|---|---|
| Children's Oncology Group | Arcadia, California 91006-3776 |
