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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

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I have been newly diagnosed with stage II-IV low-grade serous ovarian, fallopian tube, or primary peritoneal cancer.

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I had surgery to remove as much cancer as possible, with some cancer possibly left behind.

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My ovarian cancer is low grade and has normal p53 according to my pathology report.

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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.

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I am 18 years old or older.

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I can take medications by mouth.

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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:

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I do not have any serious or uncontrolled infections, except for a simple UTI.

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I have moderate to severe nerve damage.

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I have not had a heart attack or unstable heart pain in the last 6 months and do not have severe heart failure.

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My cancer has spread to my brain.

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I have not had hormonal therapy for my condition.

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I am allergic to letrozole or have had bad reactions to carboplatin/paclitaxel.

Timeline

Screening ~ 3 weeks3 visits

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

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

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

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

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030