Phase 2 Ovarian Cancer Trial, Terminated NCT00505661 Sponsor: M.D. Anderson Cancer Center Condition: Ovarian Cancer
Back to Ovarian Cancer

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 16 participants, all of whom received a treatment called Letrozole. Of those 16, 12 completed the study and 4 did not finish. The trial was measuring what is known as the "objective response rate" — essentially, how many participants showed a measurable change in their condition when assessed every two months using a standardised set of criteria called RECIST (a recognised method for measuring changes in tumours or similar findings on scans). The reported data shows the results were broken down across four measurement categories. According to the figures submitted, zero participants fell into each of the first two response categories, three participants fell into the third category, and six participants fell into the fourth category. It is worth noting that the data as submitted does not include labels clearly naming what each of those four categories represents (for example, complete response, partial response, stable disease, or progression), so it is not possible to describe exactly what those groupings mean without making assumptions. 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 2 Ovarian Cancer Trial, Terminated

NCT00505661
Terminated Phase 2

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

  • You have been diagnosed (confirmed by tissue testing) with a borderline or low-grade cancer of the ovary, fallopian tube, or peritoneum (the lining of the abdomen), including certain specific subtypes of these cancers.
  • Your cancer has come back or is at an advanced stage and cannot be removed by surgery, or you have measurable disease remaining after surgery.
  • Your tumor has tested positive for estrogen receptors or progesterone receptors (hormonal markers found on the cancer cells).
  • Your cancer can be measured on imaging scans such as CT or MRI (a raised CA125 blood marker alone is not enough to qualify).
  • You are older than 18 years of age.
  • Your doctors expect you to live for more than 12 weeks.
  • You are generally able to care for yourself and carry out daily activities (confirm with trial site regarding the specific fitness scale used).
  • You are willing to follow all study procedures and attend follow-up appointments.
  • You are willing and able to give written informed consent after being fully explained the study.
  • If you have had brain metastases (cancer spread to the brain), you have already been treated, your condition is neurologically stable, you do not need steroids or anti-seizure medications, and a brain scan shows no active disease.
  • Your blood counts are at a healthy enough level, including white blood cells, platelets, and haemoglobin (confirm specific values with trial site).
  • Your liver is functioning well enough, based on blood tests (confirm specific values with trial site).
  • Your kidneys are functioning well enough, based on blood tests (confirm specific values with trial site).

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.

  • You have not fully recovered from any surgery, or you have had major surgery within the last 4 weeks before joining the study.
  • Your cancer contains certain other cancer types, such as sarcoma, germ cell, or stromal elements.
  • Your cancer is intermediate or high-grade, or your tumor is borderline but contains any high-grade parts.
  • You are pregnant or breastfeeding.
  • The cancer has spread to the membranes surrounding the brain or spinal cord (confirm with trial site).
  • You have unstable heart conditions, such as an uncontrolled irregular heartbeat, or you have had a heart attack within the last 6 months.
  • You have any serious ongoing illness, infection, or other health condition that the study doctors feel makes participation unsuitable.
  • You have signs of a bowel blockage that is affecting your ability to eat or get proper nutrition.
  • You have had chemotherapy, radiation therapy, or immunotherapy within the last 4 weeks (or 6 weeks for certain specific drugs) before starting the study, or you have not yet recovered from side effects of those treatments.
  • You have previously been treated with more than 4 chemotherapy regimens (with all platinum-based treatments counted together as one regimen).
  • You have previously received a type of hormonal therapy called an aromatase inhibitor to treat your ovarian cancer.
  • You are currently taking estrogen or progesterone replacement therapy and have not stopped for at least 4 weeks before joining the study.
  • You have had another cancer in the past, unless it was certain types of skin cancer or cervical pre-cancer, or you have been completely free of any other cancer for at least 5 years.
  • You are currently receiving chemotherapy, radiation therapy, or immunotherapy at the same time as this study.
  • You have taken part in another clinical drug trial within the last 30 days.
  • You have a psychiatric condition that would prevent you from giving informed consent or participating in the study.
  • You have a known HIV infection.
  • You have inadequately treated serious blood clot conditions, such as a pulmonary embolism (clot in the lung) or deep vein thrombosis (clot in the leg), or you have a known clotting disorder.

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 24 July 2026

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 September 2003
Est. completion
1 May 2010

Where this trial was run

🇺🇸 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

Objective Response Rate Following Treatment With Letrozole

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: 24 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