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This trial is complete. It is no longer accepting participants.

NCT00004083

NCT00004083
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with ovarian epithelial cancer that has come back, confirmed by a lab test on a tissue or cell sample
  • Your cancer may have spread to other parts of the body (metastatic disease is allowed)
  • You have previously been treated with a platinum-based chemotherapy (a common type of chemotherapy for ovarian cancer)
  • Your cancer responded to that platinum-based treatment and did not get worse while you were on it
  • You had a period of at least 6 months without active disease after finishing your platinum-based treatment
  • You have at least one tumour that can be measured in two directions on a scan
  • You are 18 years of age or older
  • You are in reasonably good general health (able to carry out normal activity with minimal assistance)
  • You are expected to live for at least 3 more months
  • Your blood counts are at acceptable levels — enough white blood cells, platelets, and haemoglobin (confirm with trial site)
  • Your liver is functioning well enough, based on blood test results (confirm with trial site)
  • Your kidneys are working well enough, based on a kidney function test (confirm with trial site)
  • You have had a hearing test (audiogram) as a baseline before joining
  • If you could become pregnant, you must be willing to use effective contraception
  • You must be able to understand and give informed consent without significant confusion

Who may not be able to join:

  • You have cancer that has spread to the brain or central nervous system
  • You have uncontrolled heart disease or significant heart function problems
  • You are currently pregnant or breastfeeding
  • You have an active infection that requires treatment with systemic (whole-body) medicines
  • You have significant confusion, disorientation, or a history of major psychiatric illness that could affect your ability to give informed consent
  • You have moderate to severe nerve damage (neuropathy) either from previous cancer treatment or from other causes
  • You require a special type of intravenous nutrition that includes fats (total parenteral nutrition with lipids)
  • You have previously had an allergic reaction to cisplatin or any platinum-based product
  • You have previously received a treatment called SPI-77
  • You have had chemotherapy within the last 3 weeks (or 6 weeks for certain specific drugs — confirm with trial site)
  • You are currently receiving other cancer-fighting drugs or hormonal cancer treatments
  • You have had radiotherapy within the last 2 weeks, or are currently receiving radiotherapy
  • You have had major surgery for cancer within the last 2 weeks
  • You have taken part in another clinical trial using an experimental treatment within the last 30 days
  • You are currently using any other experimental 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
NYU Langone Health
Registry
clinicaltrials_gov
Start date
1 February 1999
Est. completion
1 December 1999

Where this trial is recruiting

🇺🇸 United States

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