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A Randomized, Double-Blind Phase 2 Study of Two Doses of Pemetrexed in the Treatment of Platinum-Resistant, Epithelial Ovarian or Primary Peritoneal Cancer


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

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Trial Information

A Randomized, Double-Blind Phase 2 Study of Two Doses of Pemetrexed in the Treatment of Platinum-Resistant, Epithelial Ovarian or Primary Peritoneal Cancer


Inclusion Criteria:



- Patient must have been diagnosed with ovarian or primary peritoneal cancer

- Patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens.

- Patient must have adequate health status.

- Patient compliance and geographic proximity that allow for adequate follow up is
required.

- Signed informed consent from the patient or legal representative is required.

Exclusion Criteria:

- Patient is pregnant or breast-feeding

- Patient has received treatment within the last 30 days with a drug that has not
received regulatory approval for any indication at the time of study entry.

- Patient has previously participated in another study investigating pemetrexed.

- Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, and
corticosteroids.

- Patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of
administration of study drug.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To assess the anti-tumor activity, as measured by tumor response rate (proportion of patients with complete or partial response, of 500 mg/m2 vs. 900 mg/m2 of pemetrexed therapy administered every 21 days

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9710

NCT ID:

NCT00109096

Start Date:

June 2005

Completion Date:

March 2007

Related Keywords:

  • Ovarian Neoplasms
  • Primary Peritoneal Cancer
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

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