Not recruiting

Study of Paclitaxel, Carboplatin and Letrozole Treatment Compared to Letrozole Alone in Patients with Stage II-IV Low-Grade Serous Ovarian or Peritoneal Cancer

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on low-grade serous carcinoma of the ovary or peritoneum. The research compares two treatment approaches: one group receives a combination of paclitaxel and carboplatin followed by letrozole maintenance therapy, while the other group receives letrozole treatment alone. Letrozole is a medication that helps block the production of estrogen, which can fuel the growth of certain cancers.

The medications used in this study include chemotherapy drugs given through an intravenous infusion (paclitaxel and carboplatin) and hormone therapy tablets (letrozole). Other hormone therapy medications that may be used include anastrozole and exemestane. The purpose is to determine if using letrozole alone works as well as combining chemotherapy with letrozole maintenance therapy for treating this type of cancer.

During the study, patients will be randomly assigned to one of two treatment groups. One group will receive chemotherapy infusions followed by daily letrozole tablets, while the other group will take only letrozole tablets. The treatment and follow-up period will continue for several years to monitor how well the cancer responds to these treatments.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your eligibility for the study will be confirmed through medical tests including blood tests to check bone marrow, kidney, and liver function
A physical examination and imaging of your chest, abdomen, and pelvis using contrast-enhanced scans will be performed
You must have completed surgery within 8 weeks before starting the study
Step 2
Treatment assignment
You will be randomly assigned to one of two treatment groups:
Group 1: Combination therapy - receiving paclitaxel and carboplatin through intravenous infusion, followed by letrozole tablets
Group 2: Single therapy - receiving only letrozole tablets
Step 3
Treatment period
If assigned to Group 1, you will receive intravenous medications at the hospital, followed by daily letrozole tablets at home
If assigned to Group 2, you will take daily letrozole tablets at home
Regular check-ups will monitor your response to treatment and any side effects
Step 4
Follow-up period
Regular medical examinations will track your progress
Imaging scans will be performed to assess how the treatment is working
Your overall health and any side effects will be monitored throughout the study
The study will continue until 2028 or until specific study goals are met

Who can join the trial?

14 criteria

Must be female aged 18 or older
Must have newly diagnosed stage II-IV low-grade serous ovarian cancer confirmed by pathology report
Must have undergone maximum tumor removal surgery within 8 weeks before study start
Must have had both ovaries and fallopian tubes removed (bilateral salpingo-oophorectomy)
Must have adequate organ function, including:
- Bone marrow: sufficient white blood cells and platelets
- Kidneys: normal creatinine levels
- Liver: normal bilirubin and liver enzyme levels
- Must have normal p53 protein expression shown by tissue testing
- Must be able to take oral medications
- Must have acceptable physical function status (ECOG score of 0-2, meaning able to care for self and be up and about more than 50% of waking hours)
- Must complete required medical examinations:
  - Physical examination within 14 days before starting
  - Imaging scans of chest, abdomen and pelvis within 28 days before starting
  - Must provide informed consent to participate in the study
  - May have had previous or current other cancers if they won't interfere with the study treatment

Who cannot join the trial?

13 criteria

Previous treatment with chemotherapy (drug treatment that kills cancer cells) for ovarian or peritoneal cancer
Having any other type of cancer in the past 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in early stages
Serious heart conditions, including uncontrolled high blood pressure or heart failure
Active or untreated infections
Known allergies or severe reactions to the study medications (letrozole, paclitaxel, or carboplatin)
Pregnancy or breastfeeding
Inability to take oral medications
Major surgery within 4 weeks before starting the study
Serious mental health conditions that could interfere with following study procedures
Participation in another clinical trial within 30 days before this study
Any condition that the study doctor believes would make participation unsafe
Male patients (study is for females only)
Age below 18 years

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Investigated drugs

Paclitaxel is a chemotherapy medication used to treat various types of cancer. It belongs to a group of drugs called taxanes and works by stopping cancer cells from dividing and growing. Carboplatin is a platinum-based chemotherapy drug that helps fight cancer by interfering with DNA repair in cancer cells, which prevents them from multiplying. Letrozole is a hormone therapy medication that belongs to a class of drugs called aromatase inhibitors. It works by reducing the amount of estrogen produced in the body, which can help slow or stop the growth of certain types of breast and ovarian cancers that need estrogen to grow. The trial compares two treatment approaches: one combining all three medications (Paclitaxel, Carboplatin, and Letrozole) versus using Letrozole alone in treating ovarian or peritoneal cancer.

What is already known about the treatment

Paclitaxel
A chemotherapy medication administered intravenously that belongs to the taxane family of drugs, which works by preventing cancer cell division by targeting tubulin in cell structures. This medication is commonly used in the treatment of various cancers, including ovarian and peritoneal carcinomas, and is often combined with other chemotherapy agents like carboplatin for enhanced effectiveness.
Carboplatin
A platinum-based chemotherapy drug given through intravenous infusion that works by binding to DNA in cancer cells, preventing them from dividing and growing. This medication is particularly effective in treating ovarian cancer and is often preferred over similar drugs due to its more manageable side effect profile.
Letrozole
An oral medication belonging to the class of aromatase inhibitors that works by reducing estrogen production in postmenopausal women by blocking the enzyme aromatase. This medication is used both as a primary treatment and maintenance therapy in hormone-sensitive cancers, including certain types of ovarian cancer, and can be administered alone or in combination with other cancer treatments.

Investigated diseases

Low-grade serous carcinoma of the ovary
A slow-growing type of cancer that develops in the ovaries from the cells that line these organs. This form of cancer typically develops gradually and tends to occur in younger women compared to other ovarian cancers. The cancer cells grow in a pattern that resembles normal ovarian tissue but can spread to nearby areas. It often affects both ovaries and can extend to the peritoneum, which is the lining of the abdominal cavity. This type of cancer has distinct cellular features when viewed under a microscope, showing well-organized cells with minimal irregularities.
Peritoneal carcinoma
A cancer that develops in the peritoneum, the thin layer of tissue that lines the inside of the abdomen and covers most of the abdominal organs. The disease begins when cells in the peritoneum start growing abnormally and form tumors. It shares many similarities with ovarian cancer in terms of how it develops and spreads throughout the abdominal cavity. The cancer can cause fluid buildup in the abdomen and may spread to nearby organs. This condition primarily affects the abdominal area and can develop in multiple locations within the peritoneal lining.