- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00068419
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the safety and efficacy of sulindac and tamoxifen in patients with recurrent desmoid tumor (DT) and primary DT that is not readily amenable to surgery or radiation therapy.
SECONDARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
California
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Monrovia, California, United States, 91016
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Given orally
Other Names:
Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Failure Free at 2 Years Following Study Entry
Time Frame: Up to 2 years
|
Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
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Up to 2 years
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Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.
Time Frame: Up to 12 months
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The percentage of patients experiencing a grade 3 or higher adverse event as assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0
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Up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients With Tumor Response From Imaging
Time Frame: Baseline up to 5 years
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Percentage of patients with a tumor response where tumor response is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST)
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Baseline up to 5 years
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Mean Change in Response Measured by MRI
Time Frame: From baseline to up to 5 years
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The mean change in response measured by MRI.
Response is assessed by the lesion size which is derived from the sum of the longest of the three orthogonal diameters (from MRI) of each target lesion.
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From baseline to up to 5 years
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Percentage of Patients Failure Free at 2 Years by Pathological Response
Time Frame: From enrollment to up to 2 years
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The failure free survival is compared by the log-rank test between patient subgroups defined by pathological response of cyclooxygenase-2 (COX-2) and estrogen/progesterone receptor expression
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From enrollment to up to 2 years
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Percentage of Patients Experiencing Short-term Endocrine Toxicity
Time Frame: At study entry
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The percentage of patients experiencing short-term endocrine toxicity between treatment groups is compared using the chi-square test
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At study entry
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Skapek, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Connective Tissue
- Neoplasms, Fibrous Tissue
- Fibroma
- Fibromatosis, Aggressive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
- Sulindac
Other Study ID Numbers
- ARST0321
- U10CA098543 (U.S. NIH Grant/Contract)
- 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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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