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Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Peritoneal Cancer

Thank you

Trial Information


Inclusion Criteria:



- Patients must have disease that can be measured.

- Patients must meet criteria for either platinum-resistant or platinum-sensitive
ovarian or peritoneal cancer.

- Patients may only have had one prior platinum-based chemotherapy regimen.

- Patients must be willing and able to stop all aspirin and NSAID medications
immediately before and for a time after each treatment cycle (approx. 5-8 days)

- Patients must have normal kidney function.

Exclusion Criteria:

- Patients may not have a Low Malignant Potential or Borderline Ovarian Tumor.

- Patients may not have received pelvic or abdominal radiotherapy.

- Patients must not have evidence of or received treatment for another cancer within
the last 5 years.

- Patients must not have been diagnosed with a heart attack in the last 6 months.

- Patients who are unwilling or unable to take folic acid tablets, vitamin B12
injections or dexamethasone tablets.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

7127

NCT ID:

NCT00055432

Start Date:

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • recurrent ovarian cancer
  • platinum-resistant
  • platinum-sensitive
  • folate receptor antagonist
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. Atlanta, Georgia