Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

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 uptake of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining sulindac with tamoxifen in treating patients who have desmoid tumor

Official Title

Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumor That is Recurrent or Not Amenable to Standard Therapy

Conditions

desmoid tumor

Study Type

Interventional

Study Design

Treatment

Further Details

OBJECTIVES: * Determine the progression-free survival of patients with desmoid tumor that is recurrent or not amenable to standard therapy treated with sulindac and tamoxifen. * Determine the safety and efficacy of this regimen, in terms of event-free survival, of these patients. * Determine the tumor response rate in patients treated with this regimen. * Correlate changes in MRI signal features of the tumor with clinical outcome in patients treated with this regimen. * Correlate pathological studies of cyclo-oxygenase-2 (COX-2) and estrogen/progesterone receptor expression in the tumor with clinical outcome in patients treated with this regimen.OUTLINE: This is a multicenter study.Patients receive oral sulindac and oral tamoxifen twice daily for up to 12 months (4 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.Patients are followed for survival.

Study Start

Eligibility & 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 fibromatosesPATIENT CHARACTERISTICS: Age * 18 and under at original diagnosisPerformance status * Karnofsky 50-100% (patients over age 16) OR * Lansky 50-100% (patients age 16 and under)Life expectancy * At least 8 weeksHematopoietic * 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 diathesisHepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT less than 2.5 times ULNRenal * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR * Creatinine normal for ageCardiovascular * No prior deep venous thrombosis * EKG normalPulmonary * Chest x-ray normalGastrointestinal * No prior significant gastrointestinal hemorrhage * No prior peptic ulcer diseaseOther * Not pregnant or nursing * Fertile patients must use effective nonhormonal contraception * No evidence of active graft-versus-host disease * No allergy to aspirinPRIOR 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 agentsChemotherapy * See Disease Characteristics * More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered * No concurrent anticancer chemotherapyEndocrine therapy * No prior estrogen antagonists for desmoid tumor * No concurrent hormonal contraceptives * No concurrent steroidsRadiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No concurrent adjuvant radiotherapySurgery * See Disease CharacteristicsOther * 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

Total Enrolment

62

Contact Details

Australia, New South Wales Children’s Hospital at Westmead, Westmead, New South Wales, 2145, Australia; RecruitingGeoffrey McCowage, MD 61-2-9845-2122 Sydney Children’s Hospital, Randwick, New South Wales, 2031, Australia; RecruitingGlenn Marshall, MD, MBBS 61-2-9382-1721 g.marshall@unsw.edu.au Australia, South Australia Women’s and Children’s Hospital, North Adelaide, South Australia, 5006, Australia; RecruitingMaria Louis Kirby, MBBS, FRACP 61-8-8161-7411 kirbym@mail.wch.sa.gov.au Australia, Victoria Royal Children’s Hospital, Parkville, Victoria, 3052, Australia; RecruitingDavid Ashley, MBBS, FRACP, PhD 61-39-345-5522 Australia, Western Australia Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia; RecruitingDavid L. Baker, MD, MBBS, FRACP, FRCPA 61-8-9340-8234