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A Trial for Patients With Advanced/Recurrent Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00190983
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : August 24, 2009
Last Update Posted : November 20, 2009
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female Drug: Pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Tumor Response [ Time Frame: baseline to measured progressive disease (up to 5 years) ]
    Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: time of initial response until documented tumor progression (up to 5 years) ]
    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

  2. Progression-Free Survival [ Time Frame: baseline until documented tumor progression (up to 5 years) ]
    The period from study entry until disease progression, death or date of last contact.

  3. Overall Survival [ Time Frame: baseline until death from any cause (up to 5 years) ]
    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190983


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

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ClinicalTrials.gov Identifier: NCT00190983    
Other Study ID Numbers: 8367
H3E-US-JMGS
First Posted: September 19, 2005    Key Record Dates
Results First Posted: August 24, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urogenital Neoplasms
 Neoplasms by Site
Uterine Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors