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| 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: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy |
| Estimated Enrollment: | 68 |
| Study Start Date: | February 2004 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed desmoid tumor, meeting 1 of the following criteria:
Newly diagnosed disease
Not amenable to complete surgical resection and/or radiotherapy
Radiographically documented recurrent or progressive disease
No prior chemotherapy or radiotherapy for the present recurrence
No other fibroblastic lesions or fibromatoses
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine adjusted according to age as follows:
Cardiovascular
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent NSAIDs for desmoid tumor
Contacts and Locations
Show 91 Study Locations| Study Chair: | Steve Skapek, MD | University of Chicago Comer Children's Hospital |
| Investigator: | R. Beverly Raney, MD | Driscoll Children's Hospital |
More Information
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00068419 History of Changes |
| Other Study ID Numbers: | CDR0000322260, COG-ARST0321 |
| Study First Received: | September 10, 2003 |
| Last Updated: | December 14, 2010 |
| Health Authority: | United States: Federal Government |
|
desmoid tumor |
|
Fibromatosis, Aggressive Fibroma Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sulindac Tamoxifen Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |