A Trial for Patients With Advanced/Recurrent Cervical Cancer

A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix

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.

Inclusion Criteria:

• 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 Criteria:

• 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