Trial Outcomes & Findings for Letrozole in Patients With Ovarian Tumors (NCT NCT00505661)

NCT ID: NCT00505661

Last Updated: 2012-04-18

Results Overview

Using RECIST criteria, Objective Response evaluated every 2 months.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 2 month intervals for first 2 years
• Results posted on: 2012-04-18

Participant Flow

Recruitment Period: 09/24/03 through 01/30/08. All participants recruited at UT MD Anderson Cancer Center.

Study terminated early due to slow patient accrual.

Participant milestones

Measure	Letrozole 2.5 mg by mouth (PO) daily
Overall Study STARTED	16
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Letrozole 2.5 mg by mouth (PO) daily
Overall Study Not Eligible	4

Baseline Characteristics

Letrozole in Patients With Ovarian Tumors

Baseline characteristics by cohort

Measure	Letrozole n=16 Participants 2.5 mg by mouth (PO) daily
Age Continuous	54 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 month intervals for first 2 years

Population: Analysis was per protocol, only 9 of 12 eligible patients were evaluable for response.

Using RECIST criteria, Objective Response evaluated every 2 months.

Outcome measures

Measure	Letrozole n=9 Participants 2.5 mg by mouth (PO) daily
Objective Response Rate Following Treatment With Letrozole Progressive Disease	6 participants
Objective Response Rate Following Treatment With Letrozole Complete Response	0 participants
Objective Response Rate Following Treatment With Letrozole Partial Response	0 participants
Objective Response Rate Following Treatment With Letrozole Stable Disease	3 participants

Adverse Events

Letrozole

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Letrozole n=16 participants at risk 2.5 mg by mouth (PO) daily
General disorders Fatigue	25.0% 4/16 • Number of events 4 • 4 years and 4 months

Additional Information

John Kavanagh, MD / Professor

UT MD Anderson Cancer Center

Phone: 713-792-2933

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place