Phase 2 Ovarian Cancer Trial, Completed NCT00053365 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 61 people, all of whom received a treatment called Irofulven. The trial was looking at how tumours responded to this treatment, what side effects of grade 3 or higher occurred (meaning more serious unwanted effects), and how long people went without their disease getting worse. Of the 61 who started, 55 completed the trial and 6 did not. The reported data shows that, when tumour responses were assessed: 7 participants had a complete response (meaning all measurable signs of tumour disappeared), 30 had a partial response (meaning tumours shrank by at least 30%), 12 had increasing disease (meaning tumours grew by at least 20% or new lesions appeared), and 6 fell into another category. Regarding more serious unwanted effects (grade 3 or 4, on a scale used to measure how severe side effects are), the reported data shows varying numbers of participants experienced these across several different categories — for example, 11 participants had a grade 3 event and 0 had a grade 4 event in one category, while in another category 16 had grade 3 and 6 had grade 4. The full breakdown across all categories was reported but the specific names of each side effect category were not included in the data provided here. For the secondary outcome, the reported data shows that the median progression-free survival — that is, the middle-point estimate for how long people went before their disease got worse — was 6.7 months, while a separate figure of 24.1 months was also reported (the data does not specify what this second figure represents, so it cannot be described further without guessing). 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, Completed

NCT00053365
Completed 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 with ovarian cancer or primary peritoneal cancer (a related cancer starting in the lining of the abdomen), confirmed by a laboratory test on a tissue sample
  • Your cancer has come back or has not gone away completely
  • You have at least one tumor that can be measured on a scan (at least 20mm using standard imaging, or at least 10mm using a spiral CT scan)
  • You have previously received one chemotherapy treatment that included a platinum-based drug (such as carboplatin or cisplatin) for your original diagnosis
  • If you have not previously received paclitaxel (a common chemotherapy drug), you may have had a second treatment course containing it
  • Your cancer responded to platinum-based treatment, but came back between 6 and 12 months after finishing it, with no signs of the cancer growing during that gap
  • You are in reasonably good general health, able to carry out daily activities (confirm with trial site for exact fitness level required based on your treatment history)
  • Your blood cell counts are at healthy enough levels (your trial team will check this with blood tests)
  • Your liver and kidney function are within acceptable ranges (your trial team will check this)
  • You have tested negative for pregnancy
  • If you are able to become pregnant, you are willing to use effective birth control during the trial

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 had a heart failure condition that required medication
  • You have had uncontrolled high blood pressure in the past 6 months
  • You are currently pregnant or breastfeeding
  • You have had another serious (invasive) cancer in the past 5 years, not including certain common skin cancers
  • You have a history of eye conditions affecting the retina or the central part of your eye (called macular degeneration)
  • You have nerve damage (affecting feeling or movement) beyond a mild level
  • You currently have an active infection being treated with antibiotics
  • You have had a bone marrow or stem cell transplant in the past
  • You have previously been treated with a drug called irofulven
  • You have received more than one additional chemotherapy treatment since your cancer came back
  • You have previously had radiation therapy covering more than a quarter of your bone marrow areas
  • You have had more than one non-chemotherapy (targeted or biological) treatment for your cancer since it came back
  • You have any other health condition that the trial doctors feel would make it unsafe for you to participate (confirm with trial site)
  • You have had recent treatments that have not been given enough time to recover from (generally at least 3 weeks are needed since most prior treatments)

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 20 July 2026

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 June 2003
Est. completion
1 July 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

Tumor Response; Frequency and Severity of Observed Adverse Events, Grade 3 or Higher According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

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: 20 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