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Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00068419
First received: September 10, 2003
Last updated: March 23, 2017
Last verified: March 2017
  Purpose
This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. 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.

Condition Intervention Phase
Desmoid Tumor
Drug: tamoxifen citrate
Drug: sulindac
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free Survival [ Time Frame: Study enrollment until time of disease progression or death as a first event (maximum follow-up 5 years) ]
    Two-year event-free survival (EFS). Events include disease progression (increase in the greatest product of 2 perpendicular diameters of any lesion by > 25% or new biopsy-proven lesions), and death in absence of disease progression. Reported as Kaplan-Meier estimate of two-year EFS proportion.


Secondary Outcome Measures:
  • Toxicity as Assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0 [ Time Frame: Up to 12 months ]
  • Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ]
  • Changes in Magnetic Resonance Imaging (MRI) Signal Features [ Time Frame: From baseline to up to 5 years ]
    MRI must include images in at least two planes with (a) pre-contrast images with the following pulse sequences T-1 weighted, fast spin echo T-2 weighted with fat saturation, and a short tau inversion recovery (STIR); and (b) post-contrast images with T-1 weighted pulse sequence with fat suppression.


Enrollment: 70
Study Start Date: February 2004
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: tamoxifen citrate
Given orally
Other Names:
  • Nolvadex
  • TAM
  • tamoxifen
  • TMX
Drug: sulindac
Given orally
Other Names:
  • Aflodac
  • Algocetil
  • Clinoril
  • SULIN
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

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 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068419

Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91016
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Skapek, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00068419     History of Changes
Other Study ID Numbers: ARST0321
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 )
U10CA098543 ( US NIH Grant/Contract Award Number )
Study First Received: September 10, 2003
Results First Received: October 7, 2013
Last Updated: March 23, 2017

Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Citric Acid
Tamoxifen
Sulindac
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 26, 2017