A Trial for Patients With Advanced/Recurrent Cervical Cancer

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pemetrexed	Pemetrexed	-

Primary Outcome Measures

Name	Time	Method
Tumor Response	baseline to measured progressive disease (up to 5 years)	Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	time of initial response until documented tumor progression (up to 5 years)	The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Progression-Free Survival	baseline until documented tumor progression (up to 5 years)	The period from study entry until disease progression, death or date of last contact.
Overall Survival	baseline until death from any cause (up to 5 years)	Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.