A Trial for Patients With Advanced/Recurrent Cervical Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Uterine Neoplasms

Genital Neoplasms, Female

Cervical Intraepithelial Neoplasia

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00190983

8367

H3E-US-JMGS

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

Female

Volunteers

No Healthy Volunteers

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