A Trial for Patients With Advanced/Recurrent Cervical Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Gynecologic Oncology Group
• Treatments: Pemetrexed

Criteria

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