Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

NCT00068419 | Completed Phase 2 Results DMC

• 5 other identifiers: ARST0321NCI-2009-00424CDR0000322260COG-ARST0321U10CA098543
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Desmoid Tumor

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Failure Free at 2 Years Following Study Entry

  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.

  Up to 2 years

• Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.

  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

  Up to 12 months

Secondary Outcomes (4)

• Percentage of Patients With Tumor Response From Imaging

  Baseline up to 5 years

• Mean Change in Response Measured by MRI

  From baseline to up to 5 years

• Percentage of Patients Failure Free at 2 Years by Pathological Response

  From enrollment to up to 2 years

• Percentage of Patients Experiencing Short-term Endocrine Toxicity

  At study entry

Study Arms (1)

Treatment (enzyme inhibitor therapy, anti-estrogen therapy)

EXPERIMENTAL

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; Drug: sulindac; Other: laboratory biomarker analysis

Interventions

tamoxifen citrate DRUG

Given orally

Also known as: Nolvadex, TAM, tamoxifen, TMX

Treatment (enzyme inhibitor therapy, anti-estrogen therapy)

sulindac DRUG

Given orally

Also known as: Aflodac, Algocetil, Clinoril, SULIN

Treatment (enzyme inhibitor therapy, anti-estrogen therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy, anti-estrogen therapy)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91016, United States

Location

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Tamoxifen; Sulindac

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Indenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

626-447-0064

Study Officials

• Stephen Skapek, MD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: February 1, 2004
• Primary Completion: April 26, 2010
• Study Completion: April 26, 2010
• Last Updated: February 19, 2020
• Results First Posted: December 4, 2013

Record last verified: 2019-02

Locations

US (1)