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