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NCT00565851

NCT00565851
Active, Not Recruiting Phase 3

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with a recurrent (come-back) cancer of the ovaries, the lining of the abdomen (peritoneal), or the fallopian tubes, confirmed by a tissue sample.
  • Your cancer is one of these specific types: serous, endometrioid, mucinous, undifferentiated, clear cell, mixed epithelial, transitional cell, malignant Brenner's tumor, or adenocarcinoma (not otherwise specified).
  • You had a complete response (cancer fully went away) after your first round of chemotherapy using platinum and taxane drugs (at least 3 cycles).
  • After finishing your first chemotherapy, your physical exam, pelvic exam, and CA-125 blood test all came back normal, and any scans taken afterwards showed no signs of disease.
  • You had at least 6 months free of cancer symptoms after finishing your first chemotherapy before your cancer came back.
  • If you received maintenance (ongoing) chemotherapy after your first treatment, it must have been stopped for at least 6 months before your cancer came back; if you received a biological or hormonal maintenance therapy, your cancer must have come back more than 6 months after finishing chemotherapy, and at least 4 weeks after your last biological therapy dose.
  • Your returning cancer must be clearly visible or detectable at the time of joining the study.
  • Your cancer must be measurable on scans — at least one tumor spot that is 20mm or larger (or 10mm or larger on a special spiral CT scan).
  • Your blood counts and organ function must be within acceptable ranges, including: enough white blood cells (infection-fighting cells), enough platelets (clotting cells), healthy kidney function, healthy liver function, and normal bilirubin levels.
  • If you joined before August 29, 2011, or plan to receive a drug called bevacizumab, your urine protein levels must be within an acceptable range (confirm with trial site).
  • If you are not a candidate for surgery to reduce the tumor, you may still be eligible for the chemotherapy part of the trial (confirm with trial site).
  • You must be well enough to carry out normal daily activities or light work (performance status 0, 1, or 2 on the GOG scale).
  • You must sign a consent form agreeing to take part and allowing your health information to be used.

Who may not be able to join:

  • You have had more than one previous course of chemotherapy (maintenance therapy on its own does not count as a second course).
  • You are currently receiving immunotherapy or radiation therapy.
  • You have previously had radiation treatment to any part of your abdomen or pelvis.
  • You have already had surgery to reduce your recurring tumor.
  • You need IV fluids or nutrition and have signs of a partial bowel blockage or bowel perforation (hole).
  • You have previously received chemotherapy for a different cancer in the abdomen or pelvis (other than ovarian, fallopian tube, or peritoneal cancer).
  • You have or have had uterine (endometrial) cancer, unless it was a very early-stage, low-risk cancer meeting specific conditions (confirm with trial site).
  • You have an infection that is not under control.
  • You have serious health problems unrelated to your cancer that could prevent you from safely completing the study.
  • You have moderate or severe nerve damage (numbness, tingling, or pain) in your hands or feet (grade 2 or higher).
  • You have had a serious allergic reaction to carboplatin, paclitaxel, or similar drugs — unless you were successfully treated again using a special desensitization program.
  • If receiving bevacizumab: you have a known allergy to certain laboratory-made antibody products (confirm with trial site).
  • You are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.
  • You have had another serious (invasive) cancer in the past 5 years, other than certain non-melanoma skin cancers, or if a previous cancer treatment would make this trial unsafe for you.
  • If receiving bevacizumab: you have active bleeding, a bleeding disorder, or a condition with a high risk of serious bleeding.
  • If receiving bevacizumab: you have a brain tumor, uncontrolled seizures, cancer that has spread to the brain, or a stroke within the past 5 years.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% 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
Active, Not Recruiting
Phase
Phase 3
Sponsor
National Cancer Institute (NCI)
Registry
clinicaltrials_gov
Start date
6 December 2007
Est. completion
30 April 2019

Where this trial is recruiting

🇯🇵 Japan 🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer; To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov