Active not recruitingPHASE3INTERVENTIONAL

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

This research trial is for women with advanced ovarian, fallopian tube, or primary peritoneal cancer (stages II, III, or IV). Doctors are comparing two different schedules for giving a chemotherapy drug called paclitaxel, alongside another chemotherapy drug, carboplatin. Some patients will also receive an additional drug called bevacizumab. The aim is to find out if giving paclitaxel weekly is better than giving it every three weeks, in terms of how long patients stay well and how long they live. Researchers also want to understand the side effects and how these treatments affect a patient's quality of life. The study helps doctors learn the best ways to fight these cancers.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

National Cancer Institute (NCI)

Enrolment target

692

Start

27 Sep 2010

Estimated completion

02 Jul 2026

Results

Results from this study

Posted January 2018

Results have been published for this study.

Primary outcome

Progression-Free Survival

First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Full results on the registry

What is this study about?

This study is a clinical trial, which means it's a research study involving people. It's looking into new ways to treat certain types of cancer that affect women: ovarian cancer, fallopian tube cancer, and primary peritoneal cancer, especially when they are in more advanced stages (stages II, III, or IV). The main goal is to compare two common chemotherapy drugs, paclitaxel and carboplatin, and see if adding another drug, bevacizumab, makes the treatment more effective.

Chemotherapy drugs like paclitaxel and carboplatin work by stopping cancer cells from growing, dividing, or spreading. Bevacizumab is a different kind of drug; it works by blocking the blood vessels that cancers need to grow. In this study, doctors are specifically comparing how often paclitaxel is given – either once a week or once every three weeks – to see if one schedule works better than the other when combined with carboplatin, and potentially bevacizumab. They want to find treatments that help patients live longer and with fewer unpleasant side effects.

The study also looks at how these treatments affect a patient's overall well-being and daily life. By comparing different treatment approaches, researchers hope to improve care for women with these types of cancer. This kind of research is vital for finding new and better ways to treat cancer in the future.

Key takeaways

Targets advanced ovarian, fallopian tube, or primary peritoneal cancer.
Compares weekly vs. every-three-week paclitaxel chemotherapy.
Involves paclitaxel, carboplatin, and potentially bevacizumab.
Aims to improve treatment effectiveness and reduce side effects.
Includes regular monitoring and assessments of well-being.

Who may be eligible?

This study is for women who have been diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Your cancer needs to be at a stage II, III, or IV. This study focuses on certain types of these cancers, for example, those that are called serous, endometrioid, or mucinous.

You would be considered for this study if you have visible cancer that doctors can measure using scans. This is often checked after your first surgery. If you had surgery, your doctors need to have found a certain amount of cancer remaining, or if you are having chemotherapy before surgery, they need to have confirmed the cancer type through a tissue sample (biopsy).

Essentially, the study is looking for women aged 18 or older who are newly diagnosed with these types of advanced cancers and meet specific conditions around their diagnosis and whether the cancer can be measured.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer?
Has your doctor confirmed your specific type of cancer?
Is there a measurable amount of cancer that can be seen on scans or confirmed by biopsy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive standard cancer treatments. These will include chemotherapy drugs called paclitaxel and carboplatin. Your doctors will decide if you also receive another drug called bevacizumab. The main difference in this study is how often one of the chemotherapy drugs, paclitaxel, is given – either weekly or every three weeks.

Throughout the study, you'll have regular hospital visits, including scans like CT scans, to check how your treatment is working. Doctors will also monitor you closely for any side effects and may ask you about your quality of life. The total length of your participation will depend on your treatment plan and how you respond, but follow-up check-ups will continue for some time after your main treatment is finished.

Potential risks and benefits

Participating in this study might offer you access to new ways of giving established treatments that could be more effective. However, there's no guarantee the treatment will work for you, and like all medical treatments, there may be side effects. These can vary from person to person. As with any clinical trial, you are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (564)

University of Alabama at Birmingham Cancer Center
Verified postcode
Birmingham, United States
University of South Alabama Mitchell Cancer Institute
Verified postcode
Mobile, United States
Providence Alaska Medical Center
Verified postcode
Anchorage, United States
Saint Joseph's Hospital and Medical Center
Verified postcode
Phoenix, United States
Mayo Clinic in Arizona
Verified postcode
Scottsdale, United States
University of Arizona Cancer Center-Orange Grove Campus
Verified postcode
Tucson, United States
Banner University Medical Center - Tucson
Verified postcode
Tucson, United States
University of Arizona Cancer Center-North Campus
Verified postcode
Tucson, United States
CHI Saint Vincent Cancer Center Hot Springs
Verified postcode
Hot Springs, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
Kaiser Permanente-Deer Valley Medical Center
Verified postcode
Antioch, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Verified postcode
Burbank, United States

Common questions

What types of cancer is this study looking at?

This study is for women with advanced ovarian, fallopian tube, or primary peritoneal cancer (stages II, III, or IV).

What drugs are involved in this study?

The study involves chemotherapy drugs paclitaxel and carboplatin. Some patients may also receive bevacizumab.

What's the main difference in treatment being tested?

The study is comparing two different ways of giving paclitaxel chemotherapy: either once a week or once every three weeks.

Why is this research important?

This research helps doctors understand which treatment schedule is most effective, has the fewest side effects, and best improves the quality of life for patients.

Will I have scans if I join the study?

Yes, you will have regular scans, like CT scans, to monitor your treatment progress.