A Trial for Patients With Advanced/Recurrent Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190983
First received: September 12, 2005
Last updated: November 13, 2009
Last verified: November 2009
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: time of initial response until documented tumor progression (up to 5 years) ] [ Designated as safety issue: No ]
  • Progression-Free Survival [ Time Frame: baseline until documented tumor progression (up to 5 years) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: baseline until death from any cause (up to 5 years) ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00190983

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00190983     History of Changes
Other Study ID Numbers: 8367, H3E-US-JMGS
Study First Received: September 12, 2005
Results First Received: October 21, 2008
Last Updated: November 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Genital Neoplasms, Female
Uterine Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014