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Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT00634894 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-04-20

No results posted yet for this study

Summary

Primary Objective:

1\. Evaluate the efficacy of letrozole to increase the duration of progression-free survival (defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125) when used as adjuvant treatment after completion of primary surgery and first line platinum containing chemotherapy in patients with optimally debulked (\< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer.

Secondary Objective:

1\. Observe the incidence of local and distant recurrences.

Conditions

Interventions

DRUG

Femara

2.5 mg by mouth daily x 12 weeks

DRUG

Placebo

Placebo capsule by mouth daily x 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Judith Wolf, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634894 on ClinicalTrials.gov