Phase 2 N=29 Treatment

A Trial for Patients With Advanced/Recurrent Cervical Cancer

Cervical Intraepithelial Neoplasia · Uterine Neoplasms · Genital Neoplasms, Female

Bottom Line

View on ClinicalTrials.gov: NCT00190983 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Tumor Response — 0; 4; 16; 7 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pemetrexed (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Eli Lilly and Company
Primary completion: Oct 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Tumor Response	0; 4; 16; 7	—
SECONDARY Duration of Response	4.4	—
SECONDARY Progression-Free Survival	3.1	—
SECONDARY Overall Survival	7.4	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00190983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.