Status:
COMPLETED
A Trial for Patients With Advanced/Recurrent Cervical Cancer
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Gynecologic Oncology Group
Conditions:
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
This phase II trial is studying the antitumor activity of single agent pemetrexed 900mg/m2 IV over 10 minutes in patients with recurrent cervical cancer.
Eligibility Criteria
Inclusion
- Recurrent squamous or non-squamous cell carcinoma of the cervix with documented disease progression
- Measurable disease
- Gynecologic Oncology Group (GOG) performance status 0-2
- Patients must have received one prior systemic chemotherapy for persistent or recurrent disease
- Patients with mild to moderate renal insufficiency should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs\_ with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
- All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
- Folic Acid (350-1000 ug) must be given daily beginning approximately 5-7 days prior to first does of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
- Vitamin B12 (1000 ug) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy
Exclusion
- Prior Pemetrexed
- Patients who have received radiation to more than 25% of marrow bearing areas
- Any evidence of other malignancy within last 5 years, with exception of non-melanoma skin cancer
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00190983
Start Date
February 1 2005
End Date
October 1 2007
Last Update
November 20 2009
Active Locations (1)
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1
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States