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Aromatase Inhibitor

Letrozole +/- Chemotherapy for Ovarian Cancer

Phase 3
Recruiting
Led By Amanda N Fader
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have newly diagnosed, stage II-IV low-grade serous ovarian cancer (submission of pathology report[s] required). Ovarian cancer = ovarian, fallopian tube and primary peritoneal cancers
Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (=< 1 cm diameter residual disease/nodule) or suboptimal residual disease (> 1 cm diameter residual disease/nodule) status allowed
Must not have
Patients with active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection
Patients with >= grade 2 baseline neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the randomized treatment assignment to documentation of disease progression (response evaluation criteria in solid tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether Letrozole, with or without Paclitaxel and Carboplatin, can effectively treat patients with Stage II-IV Low-Grade Serous Carcinoma of the ovary, fallopian tube, or peritoneum.

Who is the study for?
This trial is for adults with stage II-IV low-grade serous ovarian, fallopian tube, or primary peritoneal cancer. They must have had surgery to remove the cancer and be able to take oral medications. People can't join if they've had chemotherapy or radiotherapy for this disease before, are allergic to letrozole or carboplatin/paclitaxel, have severe heart issues, brain metastases, uncontrolled infections, significant neuropathy or untreated HIV.
What is being tested?
The study is testing whether letrozole alone or combined with chemotherapy drugs paclitaxel and carboplatin is more effective in treating certain types of gynecological cancers compared to just chemotherapy. Letrozole lowers estrogen which may stop tumor growth; chemo kills or stops the spread of cancer cells.
What are the potential side effects?
Letrozole might cause hot flashes, joint pain and fatigue. Chemotherapy with paclitaxel and carboplatin can lead to hair loss, nerve damage (neuropathy), nausea/vomiting and increased risk of infection due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with stage II-IV low-grade serous ovarian, fallopian tube, or primary peritoneal cancer.
Select...
I had surgery to remove as much cancer as possible, with some cancer possibly left behind.
Select...
My ovarian cancer is low grade and has normal p53 according to my pathology report.
Select...
My cancer shows normal p53 protein levels.
Select...
I can care for myself and am up and about more than 50% of my waking hours.
Select...
I am 18 years old or older.
Select...
I can take medications by mouth.
Select...
I have had surgery to remove both ovaries and fallopian tubes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any serious or uncontrolled infections, except for a simple UTI.
Select...
I have moderate to severe nerve damage.
Select...
I have not had a heart attack or unstable heart pain in the last 6 months and do not have severe heart failure.
Select...
My cancer has spread to my brain.
Select...
I have not had hormonal therapy for my condition.
Select...
I am allergic to letrozole or have had bad reactions to carboplatin/paclitaxel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the randomized treatment assignment to documentation of disease progression (response evaluation criteria in solid tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the randomized treatment assignment to documentation of disease progression (response evaluation criteria in solid tumors 1.1) or death from any cause, whichever comes first, assessed up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Letrozole
Duration of response
Incidence of adverse events (AE)
+2 more

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538
10%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (letrozole)Experimental Treatment4 Interventions
Patients receive letrozole PO QD. Cycles repeat every 21 days for up to 6 cycles. Patients then receive letrozole orally PO QD in the absence of disease progression or unacceptable toxicity as maintenance therapy. Patients undergo blood collection and tumor biopsy during screening as well as medical imaging throughout the study.
Group II: Arm I (paclitaxel, carboplatin, letrozole)Experimental Treatment6 Interventions
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Cycles repeat every 21 days for up to 6 cycles. Patients then receive letrozole PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection and tumor biopsy during screening as well as medical imaging throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Carboplatin
2014
Completed Phase 3
~6120
Letrozole
2002
Completed Phase 4
~3590
Paclitaxel
2011
Completed Phase 4
~5370

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,893 Previous Clinical Trials
41,012,022 Total Patients Enrolled
NRG OncologyLead Sponsor
237 Previous Clinical Trials
102,324 Total Patients Enrolled
Amanda N FaderPrincipal InvestigatorNRG Oncology

Media Library

Letrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04095364 — Phase 3
Fallopian Tube Cancer Research Study Groups: Arm I (paclitaxel, carboplatin, letrozole), Arm II (letrozole)
Fallopian Tube Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT04095364 — Phase 3
Letrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04095364 — Phase 3
Fallopian Tube Cancer Patient Testimony for trial: Trial Name: NCT04095364 — Phase 3
~138 spots leftby Feb 2027
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