Phase 2 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 70 years old.
• You have been diagnosed with epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) at first-line stage, or you have recurrent/metastatic cervical cancer.
• You are planned to receive 3 to 6 cycles of a specific chemotherapy combination (paclitaxel with carboplatin or cisplatin, with or without bevacizumab).
• You are generally able to carry out basic daily activities and care for yourself (confirm with trial site regarding exact fitness level required).
• Your doctor expects you to live for more than 3 months.
• Your blood test results before joining show your white blood cells, red blood cells, and platelets are at acceptable levels (confirm specific numbers with trial site).
• You have at least one personal factor that increases your risk of developing a fever due to low white blood cell counts, such as: being over 65 and receiving full-dose chemotherapy; having had previous chemotherapy or radiotherapy; having persistently low white blood cells; cancer that has spread to your bone marrow; a recent surgery or open wound; reduced liver function; reduced kidney function; a previous episode of fever with low white blood cells; a blood or lymph system cancer at the same time; a weakened immune system; or poor nutrition or physical condition.
• Your heart is pumping blood effectively, with a heart pump function score above 50% (confirm with trial site).
• You are not able to become pregnant (either post-menopausal for at least one year, or have had a sterilisation procedure), OR if you could become pregnant, you agree to use reliable contraception from one month before the trial starts until 30 days after it ends.
• You are willing to sign a consent form and follow the study procedures.
• The trial doctor has decided you are well enough to tolerate the study drug (Efgbemalenograstim alfa).

Who may not be able to join:

• You have an infection that is not under control, or you have been taking antibiotics within 72 hours before starting chemotherapy.
• You are currently pregnant or breastfeeding.
• You have previously had a bone marrow or stem cell transplant.
• You have another type of cancer at the same time, other than the ovarian or cervical cancer being treated.
• You have been treated with a white-blood-cell-boosting injection (a type called G-CSF) within the past 6 weeks.
• You have a psychiatric (mental health) illness or cancer that has spread to your brain.
• You have signs of serious heart problems, such as heart failure, a weakened heart muscle, or a recent heart attack.
• You have a condition that causes an enlarged spleen.
• You have an active infection, hepatitis C, or active hepatitis B within the past year (unless a test before joining confirms you are negative for hepatitis B).
• You are allergic to G-CSF medicines, any ingredients in the study drug, or rubber/latex.
• You have tested positive for HIV or have AIDS.
• You have active tuberculosis (TB), have recently been in close contact with someone who has TB (unless your TB skin test is negative), are being treated for TB, or have a suspicious finding on a chest X-ray.
• You have sickle cell anaemia.
• You have taken part in another clinical drug trial within the past month.
• You regularly misuse alcohol or drugs in a way that may affect your ability to follow the study rules.
• The trial doctor believes you have a health condition or symptom that makes it unsafe or unsuitable for you to take part.

Important: Always verify eligibility with the trial site directly before applying.