Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Lee-May Chen
Photo of Lee-May Chen
Lee-May Chen

Description

Summary

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.

Official Title

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

Details

PRIMARY OBJECTIVE: I. To examine if letrozole monotherapy/maintenance (L/L) is non-inferior to intravenous (IV) paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to progression-free survival (PFS) in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction. SECONDARY OBJECTIVES: I. To compare the nature, frequency and maximum degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 for each treatment arm. II. To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm. III. To compare overall survival for each treatment arm. IV. To compare the CT/L and L/L arms with respect to patients' adherence to letrozole therapy as measured by pill counts. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: 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 orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive letrozole PO QD in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

Keywords

Low Grade Fallopian Tube Serous Adenocarcinoma Low Grade Ovarian Serous Adenocarcinoma Primary Peritoneal Low Grade Serous Adenocarcinoma Stage II Fallopian Tube Cancer AJCC v8 Stage II Ovarian Cancer AJCC v8 Stage II Primary Peritoneal Cancer AJCC v8 Stage IIA Fallopian Tube Cancer AJCC v8 Stage IIA Ovarian Cancer AJCC v8 Stage IIA Primary Peritoneal Cancer AJCC v8 Stage IIB Fallopian Tube Cancer AJCC v8 Stage IIB Ovarian Cancer AJCC v8 Stage IIB Primary Peritoneal Cancer AJCC v8 Stage III Fallopian Tube Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Primary Peritoneal Cancer AJCC v8 Stage IIIA Fallopian Tube Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Primary Peritoneal Cancer AJCC v8 Stage IIIA1 Fallopian Tube Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Fallopian Tube Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Fallopian Tube Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Primary Peritoneal Cancer AJCC v8 Stage IIIC Fallopian Tube Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Primary Peritoneal Cancer AJCC v8 Stage IV Fallopian Tube Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Primary Peritoneal Cancer AJCC v8 Stage IVA Fallopian Tube Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Primary Peritoneal Cancer AJCC v8 Stage IVB Fallopian Tube Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Primary Peritoneal Cancer AJCC v8 Adenocarcinoma Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Peritoneal Neoplasms Cystadenocarcinoma, Serous Paclitaxel Carboplatin Albumin-Bound Paclitaxel Letrozole

Eligibility

You can join if…

Open to females ages 18 years and up

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • All women will, by definition, be considered menopausal due to surgical removal of both ovaries prior to trial enrollment
  • 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. p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53). 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). 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
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 14 days prior to registration
  • Contrast-enhanced imaging of the chest, abdomen and pelvis within 28 days prior to registration
  • 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

You CAN'T join if...

  • 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
  • Patients may not have received neoadjuvant 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

  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Kaiser Permanente-San Francisco accepting new patients
    San Francisco California 94115 United States
  • Community Cancer Institute accepting new patients
    Clovis California 93611 United States
  • University Oncology Associates accepting new patients
    Clovis California 93611 United States
  • Fresno Cancer Center accepting new patients
    Fresno California 93720 United States
  • Kaiser Permanente-Fresno accepting new patients
    Fresno California 93720 United States
  • Kaiser Permanente Cancer Treatment Center accepting new patients
    South San Francisco California 94080 United States
  • Kaiser Permanente-South San Francisco accepting new patients
    South San Francisco California 94080 United States

Lead Scientist at UCSF

  • Lee-May Chen
    Dr. Lee-may Chen is the Division Director and Program Director for the UCSF/KPSF Gynecologic Oncology Fellowship Program. She is deeply committed to education and improving the outcomes of gynecologic cancer care. Since 2008, I have been the director of the UCSF Gynecologic Cancer Risk Program.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NRG Oncology
ID
NCT04095364
Phase
Phase 3
Study Type
Interventional
Last Updated