Brief Title
A Trial for Patients With Advanced/Recurrent Cervical Cancer
Official Title
A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix
Brief 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor Response
Secondary Outcome
Duration of Response
Condition
Cervical Intraepithelial Neoplasia
Intervention
Pemetrexed
Study Arms / Comparison Groups
Pemetrexed
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
February 2005
Completion Date
October 2007
Primary Completion Date
October 2007
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David Miller, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00190983
Organization ID
8367
Secondary IDs
H3E-US-JMGS
Study Sponsor
Eli Lilly and Company
Collaborators
Gynecologic Oncology Group
Study Sponsor
David Miller, MD, Study Chair, Gynecologic Oncology Group
Verification Date
November 2009