CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 139 enrolled
Drug / intervention
tamoxifen citrate +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Histologically confirmed stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with only 1 prior first-line chemotherapy regimen (platinum/taxane-based)
  • Clinically and radiologically without evidence of measurable and nonmeasurable disease
  • Biochemical recurrence: CA 125 normalized during first-line therapy then rose to exceed twice the upper limit of normal
  • CA 125 <100 U/mL must be confirmed a second time within 4 weeks; CA 125 ≥100 U/mL may be entered without confirmatory measurement
Key exclusion· 6
  • No prior immunotherapy, biological response modifiers, or antiangiogenic agents
  • No prior or concurrent tamoxifen or other selective estrogen receptor modulators
  • No grade 2 or greater sensory or motor neuropathy
  • No other malignancy within past 5 years except nonmelanoma skin cancer or carcinoma in situ

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

Search/NCT00041080
NCT00041080Phase 3Completed

A Randomized Study Of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer Of The Fallopian Tube, And Primary Peritoneal Carcinoma After First Line Chemotherapy

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Jul 30, 2019

In Brief

A Phase 3 clinical trial evaluating tamoxifen citrate, thalidomide, and 1 other intervention for Fallopian Tube Cancer and 4 related conditions. Completed, enrolled 139 participants across 1 site.

Detailed Summary

Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Study Details

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartFeb 1, 2003
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 23.4 years ago

Interventions

tamoxifen citratedrug

Given orally

thalidomidedrug

Given orally

laboratory biomarker analysisother

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