Phase 3 Ovarian Cancer Trial, Active, Not Recruiting NCT00565851 Sponsor: National Cancer Institute (NCI) Condition: Ovarian Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 1,052 participants across eight treatment groups. All participants had recurrent platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The trial was measuring two main things: whether performing additional surgery (called cytoreductive surgery, which aims to remove as much tumour as possible) before chemotherapy made a difference to how long patients lived overall, and whether adding a medicine called bevacizumab to standard chemotherapy (carboplatin and paclitaxel) made a difference to overall survival. The trial also tracked how long it took for the cancer to progress, and collected information on side effects and quality of life. The reported data shows that, for the surgery question, participants who did not have cytoreductive surgery had a reported median overall survival of 64.7 months, compared with 50.6 months for those who did have the surgery. (Median means the middle value — half the participants lived longer than this, half shorter.) For the bevacizumab question, participants who received carboplatin and paclitaxel alone had a reported median overall survival of 37.3 months, while those who also received bevacizumab had a reported median of 42.2 months. Regarding how long it was before the cancer progressed (called progression-free survival), the reported data shows 10.4 months for chemotherapy alone versus 13.8 months for chemotherapy plus bevacizumab, and 16.2 months for no surgery versus 18.9 months for surgery. The reported data also shows that 804 of the treated participants across all arms experienced at least one adverse event (an unwanted or unexpected reaction). Quality-of-life scores, measured on a scale of 0 to 100, were reported as broadly similar between the chemotherapy-with-bevacizumab and chemotherapy-alone groups across the time points measured, with scores generally in the low-to-mid 70s for both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Ovarian Cancer Trial, Active, Not Recruiting

NCT00565851
Active, Not Recruiting Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with a recurrent form of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer through a tissue biopsy.
  • People whose cancer is one of these specific types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified.
  • People who had a complete response (no signs of disease) after their first course of platinum and taxane chemotherapy (at least three cycles).
  • People whose complete response included a normal physical exam, normal pelvic exam, and normal CA125 blood test levels (if the CA125 was elevated at the start of treatment).
  • People who had at least 6 months free from signs of disease progression after finishing their first course of chemotherapy.
  • People whose cancer has now come back and is measurable — meaning at least one tumour that can be measured at 20mm or larger using standard scans, or 10mm or larger using spiral CT scanning.
  • People whose blood counts and organ function fall within acceptable ranges, including adequate white blood cell counts, platelets, kidney function, liver function, and related markers.
  • People who are able to care for themselves or carry out light activities (a performance status rating of 0, 1, or 2 on the GOG scale).
  • People enrolled after August 28, 2011 who are willing to have their surgical treatment decided by random assignment, if they are suitable candidates for tumour-reduction surgery.
  • People who have signed an approved consent form allowing their health information to be used for the study.
  • People who were previously diagnosed with a low-grade (borderline) ovarian tumour that was removed by surgery and who later developed a separate, new invasive ovarian or peritoneal cancer — provided all other criteria are met.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have had more than one previous course of chemotherapy (note: maintenance therapy is not counted as a separate course).
  • People currently receiving immunotherapy or radiation therapy at the same time.
  • People who have previously had radiation therapy to any part of the abdomen or pelvis.
  • People who have already had a second surgery to remove recurrent tumours before joining this trial.
  • People who need IV fluids or nutrition through a drip, or who have signs of a partial bowel blockage or bowel perforation.
  • People who have previously received chemotherapy for any other abdominal or pelvic cancer (other than ovarian, fallopian tube, or primary peritoneal cancer).
  • People with a history of uterine (endometrial) cancer, unless specific conditions are all met: the cancer was no higher than stage I-B, involved only a shallow layer of the uterine wall, had no spread into blood or lymph vessels, and was not a high-grade or aggressive type.
  • People with an active, uncontrolled infection.
  • People with serious medical conditions unrelated to their cancer that would make it unsafe or unrealistic to complete the study.
  • People with moderate or severe nerve damage in their hands or feet (grade 2 or higher peripheral neuropathy).
  • People with a history of serious allergic reactions to carboplatin or paclitaxel, unless they have been successfully treated again after completing a desensitisation programme.
  • People who are pregnant, breastfeeding, or of childbearing potential and not using adequate contraception.
  • People with another active invasive cancer (other than certain non-melanoma skin cancers), or who have had another cancer with evidence of disease within the past 5 years, or whose prior cancer treatment would conflict with this trial's treatment.
  • People with uncontrolled high blood pressure, a recent heart attack, unstable chest pain, significant heart rhythm problems, moderate or severe heart failure, or serious blood vessel disease — this applies to those enrolled before August 29, 2011, or those enrolled later who are receiving bevacizumab.
  • People with a known allergy to certain biological laboratory-produced antibody products — this applies to those enrolled before August 29, 2011, or those enrolled later who are receiving bevacizumab.
  • People with active or high-risk bleeding conditions, known bleeding disorders, or tumours growing near major blood vessels — this applies to those enrolled before August 29, 2011, or those enrolled later who are receiving bevacizumab.
  • People with a history of brain tumours, uncontrolled seizures, cancer spread to the brain, or a stroke within the past 5 years — this applies to those enrolled before August 29, 2011, or those enrolled later who are receiving bevacizumab.
  • People who have had a major surgery, open biopsy, dental extraction, or significant injury within 28 days before starting treatment, or who have had a vascular access device or core biopsy placed within 7 days before starting treatment — this applies to those enrolled before August 29, 2011, or those enrolled later who are receiving bevacizumab.
  • People with a urine protein-to-creatinine ratio of 1.0 or higher — this applies to those enrolled before August 29, 2011, or those enrolled later who are receiving bevacizumab.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

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Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
6 December 2007
Est. completion
30 April 2019

Where this trial was run

🇯🇵 Japan 🇰🇷 South Korea 🇺🇸 United States

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

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

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov