DISCLAIMER: This site is for informational purposes only. While we make every effort to keep it up to date, there is no guarantee that information is complete, accurate, comprehensive, or the same for all KP regions. The information on this site should not be interpreted or used as a substitute for professional medical care. Please consult your care provider for any personal health questions or before participating in clinical trials.

Active, currently enrolling

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

NCT No.: NCT04095364

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: 

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

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

Sex

Male & Female

Age Limit

Eligibility Criteria

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

Sponsors

  • NRG Oncology

Find a study