KPStudySearch

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

Overall Recruitment Status: Active, currently enrolling

Official Title

Region

Sponsors

California - Northern

NRG Oncology

Acronym

NCT No.

NCT04095364

Study Type

Phase

INTERVENTIONAL

Phase III

Purpose

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

Detailed Description

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

Keywords and/or Specific Medical Conditions

Abdominal Neoplasms	Genital Diseases, Female
Adenocarcinoma	Genital Neoplasms, Female
Adnexal Diseases	Gonadal Disorders
Albumin-Bound Paclitaxel	Hormone Antagonists
Antimitotic Agents	Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents	Letrozole
Antineoplastic Agents, Phytogenic	Mitosis Modulators
Aromatase Inhibitors	Molecular Mechanisms of Pharmacological Action
Carboplatin	Neoplasms
Carcinoma	Neoplasms by Histologic Type
Carcinoma, Ovarian Epithelial	Neoplasms by Site
Cystadenocarcinoma	Neoplasms, Cystic, Mucinous, and Serous
Cystadenocarcinoma, Serous	Neoplasms, Glandular and Epithelial
Digestive System Diseases	Ovarian Diseases
Digestive System Neoplasms	Ovarian Neoplasms
Endocrine Gland Neoplasms	Paclitaxel
Endocrine System Diseases	Peritoneal Diseases
Enzyme Inhibitors	Peritoneal Neoplasms
Estrogen Antagonists	Physiological Effects of Drugs
Fallopian Tube Diseases	Steroid Synthesis Inhibitors
Fallopian Tube Neoplasms	Tubulin Modulators
Female Urogenital Diseases	Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications	Urogenital Neoplasms
Genital Diseases	Oncology (Adult)

KP Clinical Facility

All Kaiser Permanente Northern California Medical Centers
Central Valley-Modesto
Central Valley-Stockton
Diablo Medical Center-Deer Valley
Fremont Medical Center
Fresno Medical Center
Oakland Medical Center
Richmond Medical Center
Roseville Medical Center
Sacramento Medical Center
San Leandro Medical Center
San Rafael Medical Center
Santa Clara Medical Center-Homestead
Santa Rosa Medical Center
Santa Teresa Medical Center-San Jose
South Sacramento Medical Center
South Sacramento Medical Center-Elk Grove
South San Francisco Medical Center
Vallejo Medical Center
Vallejo Medical Center-Vacaville