Status:
COMPLETED
A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Gynecologic Oncology Group
Conditions:
Ovarian Cancer
Peritoneal Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progress...
Eligibility Criteria
Inclusion
- Histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer
- Measurable disease
- Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel
- Treatment-free interval \< 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
- Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e., any active phase III GOG protocol for the same patient population)
Exclusion
- Patients who have had prior therapy with pemetrexed
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- Patients who have received radiation to more than 25% of marrow
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00461786
Start Date
September 1 2004
End Date
May 1 2008
Last Update
December 4 2009
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Philadelphia, Pennsylvania, United States