This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

A Trial for Patients With Advanced/Recurrent Cervical Cancer

This study has been completed.
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company Identifier:
First received: September 12, 2005
Last updated: November 13, 2009
Last verified: November 2009
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.

Condition Intervention Phase
Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female Drug: Pemetrexed Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Tumor Response [ Time Frame: baseline to measured progressive disease (up to 5 years) ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: time of initial response until documented tumor progression (up to 5 years) ]
  • Progression-Free Survival [ Time Frame: baseline until documented tumor progression (up to 5 years) ]
  • Overall Survival [ Time Frame: baseline until death from any cause (up to 5 years) ]

Enrollment: 29
Study Start Date: February 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00190983

United States, Pennsylvania
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Eli Lilly and Company
Gynecologic Oncology Group
Study Chair: David Miller, MD Gynecologic Oncology Group
  More Information

Additional Information: Identifier: NCT00190983     History of Changes
Other Study ID Numbers: 8367
Study First Received: September 12, 2005
Results First Received: October 21, 2008
Last Updated: November 13, 2009

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on August 17, 2017