Back to Ovarian Cancer
NCT02713386
NCT02713386
Who may be able to join
Who might be able to join this trial:
- You have been diagnosed with (or are strongly suspected to have) advanced ovarian, fallopian tube, or peritoneal cancer (stage III or IV) that has not been treated yet, and your doctors plan to give you chemotherapy before surgery.
- Your cancer has been confirmed through a tissue biopsy (not just a fluid sample), and the cancer type is high grade serous, high grade endometrioid, clear cell, or a combination of these.
- Your cancer can be measured on a scan (CT, MRI, or X-ray), with at least one visible tumor of a specific minimum size.
- You have had a physical exam and body scans (chest, abdomen, and pelvis) within the last 28 days confirming your diagnosis.
- You are in reasonably good general health — able to carry out some daily activities, even if not fully (confirm with trial site for exact fitness level required).
- Your blood counts are healthy enough: sufficient white blood cells, platelets, and hemoglobin levels (blood transfusions are allowed to reach the required hemoglobin level).
- Your kidneys are working well enough, based on a standard calculation using a recent blood test.
- Your liver function tests are within an acceptable range.
- You have little or no nerve damage (numbness, tingling, or weakness).
- You are able to swallow and keep down oral (by mouth) medication.
- You are willing to sign a consent form agreeing to take part in the study.
- You have had genetic testing for BRCA1 and BRCA2 gene changes (required for patients joining under the most recent version of the study rules).
Who may not be able to join:
- Your doctors suspect your cancer may have started somewhere other than the female reproductive system, such as the digestive tract.
- You have had another serious (invasive) cancer in the last 3 years (or 2 years for breast cancer), not counting certain skin cancers; or your previous cancer treatment would conflict with this trial's treatment.
- You have received chemotherapy for any abdominal or pelvic cancer in the last 3 years (prior breast cancer chemotherapy completed more than 2 years ago may be acceptable — confirm with trial site).
- You have had radiation therapy to your abdomen, pelvis, or chest area in the last 3 years (prior radiation to the head, neck, or skin completed more than 3 years ago may be acceptable — confirm with trial site).
- You have already received any targeted therapy, antibody treatment, or hormonal therapy specifically for your ovarian, fallopian tube, or peritoneal cancer.
- Your cancer is of a type called mucinous, low grade endometrioid, low grade serous, or carcinosarcoma.
- You have (or have had) uterine cancer at the same time, unless it was a very early-stage, low-grade case meeting specific conditions (confirm with trial site).
- You have a serious active infection currently requiring antibiotics, antifungal, or antiviral medicines.
- You have cancer that has spread to the brain or nervous system, or you have a history of uncontrolled seizures.
- You have significant heart problems, such as unstable chest pain, a heart attack within the last 6 months, severe heart failure, or a serious irregular heartbeat requiring medication.
- You have a blockage in your digestive system (partial or complete).
- You are not considered healthy enough to undergo major abdominal surgery due to other medical conditions.
- You have any condition that the trial doctor believes would make participation unsafe or difficult for you.
- You are unwilling to receive a blood transfusion if needed.
- You are currently receiving any other cancer treatment (chemotherapy, radiation, immunotherapy, hormonal therapy, or another trial drug).
- You have taken a drug as part of another clinical trial within the last 30 days (or longer, depending on the drug) before starting this trial.
- The trial doctor believes you are unlikely or unable to follow the treatment schedule and study visits.
- You are currently pregnant or breastfeeding; women who could become pregnant must use effective contraception throughout the study and must have a negative pregnancy test before starting.
- You have a known history of HIV, hepatitis B, hepatitis C, or tuberculosis.
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.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
NRG Oncology
Registry
clinicaltrials_gov
Start date
14 November 2016
Est. completion
30 September 2021
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Dose-limiting Toxicities (Phase I); Progression-free Survival (PFS) (Phase II)
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.