NCT01253681
Who may be able to join
Who might be able to join this trial:
- You are a woman aged 18 or older who has been newly diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer (certain aggressive or advanced stages) and are planned to receive 6 cycles of paclitaxel and carboplatin chemotherapy as your first treatment
- If you have early-stage or moderately advanced disease, you must have already had surgery to remove the tumor, completed between 4 and 12 weeks before joining, and have fully recovered from that surgery
- If you have the most advanced stage of disease and have not yet had tumor-removal surgery, there must be a plan for that surgery after your first 3 cycles of treatment
- You must be in good general health, able to carry out normal activities or light work (as measured by a standard scale called GOG Performance Status 0 or 1)
- Your doctors expect you to live for at least 3 months
- You are able to start the trial treatment within 7 days of enrolling
- Your blood, kidney, and liver function results must meet certain minimum levels shown through blood and urine tests
- If you could become pregnant and are sexually active, you must agree to use a non-hormonal double-barrier method of contraception (such as a condom plus diaphragm) from signing consent through 6 months after your last dose
Who may not be able to join:
- You have already received any cancer treatment or experimental therapy for ovarian, peritoneal, or fallopian tube cancer
- You have previously had external beam radiation therapy to your abdomen or pelvis
- You are considered at higher-than-average risk of a bowel perforation (a hole in the bowel), including if you currently have a bowel blockage, have had a bowel perforation or abnormal passageway (fistula) in the past 6 months, or require intravenous nutrition
- You have had a blood clot in an artery or vein within the past 12 months
- You have had a significant bleeding episode within the past 6 months
- Your cancer has spread to your brain or central nervous system
- You have an active infection (other than a simple urinary tract infection) within the 14 days before enrolling
- You have previously been treated with AMG 386 or similar drugs that target the same biological pathway
- You are currently taking or have taken immune-suppressing medications such as cyclosporine or tacrolimus within the past 30 days
- You have previously had high-dose chemotherapy requiring a stem cell or bone marrow transplant
- You have had a significant heart problem in the past 12 months, such as a heart attack, unstable chest pain, stroke, mini-stroke, heart failure, or uncontrolled heart rhythm problems
- Your blood pressure is not well controlled (specifically, lower reading above 90 or upper reading above 140), though blood pressure medications are allowed
- You have a history of another cancer, unless it was fully treated at least 3 years ago with no sign of return, or was a minor skin cancer or early cervical cell changes that were fully treated
- You have had major surgery within the past 28 days or have not yet fully recovered from a previous surgery
- You have had a minor surgical procedure, including placement of a central line (a tube for delivering medicines), within the past 3 days
- You have a known allergy to bacterially-produced proteins, or to paclitaxel or the substance used to deliver it (cremophor)
- You are pregnant, breastfeeding, or planning to become pregnant within 6 months of finishing treatment
- You have tested positive for HIV, hepatitis C, or active hepatitis B
- You have a wound, ulcer (including in the digestive tract), or bone fracture that is not healing
- You have previously enrolled in this same trial
- You will not be available for follow-up appointments after treatment
- You have a condition that affects your ability to understand and agree to take part in the study or to follow the study procedures
- Any other serious ongoing illness or medical condition that, in your doctor's opinion, makes participation unsafe or could affect the study results
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
To evaluate whether AMG 386 in combination with paclitaxel and carboplatin is safe and well tolerated in the first-line treatment of high-risk stage I and stages II-IV epithelial ovarian, primary peritoneal and fallopian tube cancers.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.