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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
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

Study 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.Check my eligibility
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.See study design
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.
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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.
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I can take medications by mouth.
Select...
I have had surgery to remove both ovaries and fallopian tubes.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
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

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 2
~1700
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Letrozole
2002
Completed Phase 4
~3240

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,682 Total Patients Enrolled
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,402 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA-approved use for Letrozole?

"Letrozole is an effective palliative treatment for patients suffering from malignant esophageal neoplasms, peritoneal neoplasms, and other cancers."

Answered by AI

Are there different facilities in the US that are participating in this research?

"To decrease the burden of travel, it is advised that patients enroll at the clinical trial site nearest to them. There are 100 locations enrolling patients in this study, which are situated in cities such as Denver, Goshen, and Norton Shores."

Answered by AI

Has Letrozole been cleared by the FDA?

"There is both anecdotal and clinical evidence backing the safety of letrozole, thus it receives a score of 3."

Answered by AI

How large is the study's test group?

"Yes, the trial is still recruiting patients. 450 participants are needed, and the study is being conducted at 100 sites."

Answered by AI

Does Letrozole have a long history of efficacy in clinical trials?

"The National Institutes of Health Clinical Center first studied letrozole in 1995. As of now, there have been a total of 1732 completed trials with 1380 still active. Many of the ongoing trials are based in Denver, Colorado."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Cancer Center at Saint Joseph's
Kaiser Permanente Medical Center - Santa Clara
Commonwealth Cancer Center-Corbin
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

If there is a chance that my condition can be treated with fewer or less infusions, I would like that.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Can I keep my doctor?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. PeaceHealth Saint Joseph Medical Center: < 48 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
2019. "Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04095364.
All > Peritoneal Carcinomatosis > Ovarian Cancer
~169 spots leftby Feb 2027
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