Clinical Trial: Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Children's Oncology Group

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: September 10, 2003
Date Started: February 2004
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017