A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Cancer Categories

Gynecologic

Karmanos Trial ID

NRG-GY019

NCT ID

NCT04095364

Age Group

Adult

Scope

National

Phase

Phase III

Principal Investigator

Robert
Morris, MD
Oncology - Gynecologic, Oncology - Surgical View Profile

Objective:

Primary Objective:

To examine if letrozole monotherapy/maintenance is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.

Secondary Objectives:

To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm.
To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm.
To compare overall survival for each treatment arm.
To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts.

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Eligibility

Inclusion Criteria:

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

NOTE: Patients with a prior history of serous borderline tumors but a new diagnosis of stage II-IV low-grade serous ovarian cancer are eligible
p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53)

A copy of the pathology report that includes the diagnosis of low grade serous ovarian cancer and nonaberrant p53 IHC result must be submitted in RAVE. NOTE: If aberrant p53 expression is found on p53 IHC, the patient is NOT eligible (aberrant p53 expression is consistent with mutant TP53 and supports diagnosis of high grade serous ovarian cancer)

Appropriate stage for study entry based on the following diagnostic workup:

History/physical examination within 14 days prior to registration;
Radiographic tumor assessment within 28 days prior to registration. (23-MAY-2023)

Age >= 18
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
Patients must have undergone a bilateral salpingo-oophorectomy
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration
Patients must be within =< 8 weeks of primary cytoreductive surgery at time of randomization
Patients must be able to take per oral (P.O.) medications
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl (within 14 days prior to registration)
Platelets greater than or equal to 100,000 cells/mcl (within 14 days prior to registration)
Creatinine less than or equal to 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
Bilirubin less than or equal to 1.5 x ULN (within 14 days prior to registration)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 x ULN (within 14 days prior to registration)
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion Criteria:

Patients may not have received neoadjuvant or adjuvant chemotherapy or radiotherapy for the treatment of this disease
Patients may not have received previous hormonal therapy for the treatment of this disease
Patients with known hypersensitivity to letrozole or hypersensitivity/intolerance to carboplatin/paclitaxel therapy
Patients with severe cardiac disease:

Myocardial infarction or unstable angina within 6 months prior to registration
New York Heart Association (NYHA) class II or greater congestive heart failure

Patients with known central nervous system metastases
Patients with active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection
Patients with >= grade 2 baseline neuropathy
Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices