A Trial for Patients With Advanced/Recurrent Cervical Cancer
Completed · Phase 2
Conditions studied: Cervical Intraepithelial Neoplasia, Uterine Neoplasms, Genital Neoplasms, Female
In brief
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.
Key facts
- Study ID
- NCT00190983
- Run by
- Eli Lilly and Company
- People needed
- 29
- Starts
- 2005-02-01
- Expected to finish
- 2007-10-01
- Last updated by the study team
- 2009-11-20
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Gynecologic Oncology Group 215-854-0770 — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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