A Trial for Patients With Advanced/Recurrent Cervical Cancer

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190983
• Other study ID #: 8367
• Secondary ID: H3E-US-JMGS
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 13, 2009
• Start date: February 2005
• Est. completion date: October 2007

Study information

• Verified date: November 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Genital Neoplasms, Female
• Neoplasms
• Uterine Neoplasms

Intervention

Drug:
• Pemetrexed
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group 215-854-0770	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response		baseline to measured progressive disease (up to 5 years)	No
Secondary	Duration of Response		time of initial response until documented tumor progression (up to 5 years)	No
Secondary	Progression-Free Survival		baseline until documented tumor progression (up to 5 years)	No
Secondary	Overall Survival		baseline until death from any cause (up to 5 years)	No

External Links

•   Lilly Clinical Trial Registry