CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
tamoxifen citrate +2 moredrug
Likely dose
Sulindac and tamoxifen citrate, both given orally (specific doses not stated)AI-extracted
Key inclusion· 8
  • ✓Histologically confirmed desmoid tumor
  • ✓Newly diagnosed, not previously treated, and not amenable to complete surgical resection and/or radiotherapy with measurable residual disease if resection was attempted
  • ✓Radiographically documented recurrent or progressive disease with no prior chemotherapy or radiotherapy for the present recurrence (prior chemotherapy allowed if patient has not received it for this recurrence)
  • ✓Measurable disease by gadolinium-enhanced MRI
Key exclusion· 8
  • ✕Other fibroblastic lesions or fibromatoses (lipofibromatosis and desmoplastic fibroma of bone are allowed)
  • ✕Hemophilia, von Willebrand disease, or other clinically significant bleeding diathesis
  • ✕Prior deep venous thrombosis
  • ✕Prior significant gastrointestinal hemorrhage or peptic ulcer disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00068419
NCT00068419Phase 2Completed
CompareCT.gov

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

Children's Oncology Group·interventional·Posted Sep 11, 2003·Updated Feb 19, 2020

In Brief

A Phase 2 clinical trial evaluating tamoxifen citrate, sulindac, and 1 other intervention for Desmoid Tumor. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDesmoid Tumor
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2003
Enrollment StartFeb 1, 2004
Primary CompletionApr 26, 2010
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 22.8 years ago

Interventions

tamoxifen citratedrug

Given orally

sulindacdrug

Given orally

laboratory biomarker analysisother

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