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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00053365

NCT00053365
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • 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:

  • 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.

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
National Cancer Institute (NCI)
Registry
clinicaltrials_gov
Start date
1 June 2003
Est. completion
1 July 2010

Where this trial is recruiting

🇺🇸 United States

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

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