Overview

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