Expired Study
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Philadelphia, Pennsylvania


Purpose:

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.


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


NCT ID:

NCT00190983


Primary Contact:

Study Chair
David Miller, MD
Gynecologic Oncology Group


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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