Back to resultsA Trial for Patients With Advanced/Recurrent Cervical Cancer
Primary Purpose
Cervical Intraepithelial Neoplasia, Uterine Neoplasms, Genital Neoplasms, Female
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Intraepithelial Neoplasia
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
Sites / Locations
- Gynecologic Oncology Group 215-854-0770
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemetrexed
Arm Description
Outcomes
Primary Outcome Measures
Tumor Response
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
Duration of Response
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.
Progression-Free Survival
The period from study entry until disease progression, death or date of last contact.
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Full Information
NCT ID
NCT00190983
First Posted
September 12, 2005
Last Updated
November 13, 2009
Sponsor
Eli Lilly and Company
Collaborators
Gynecologic Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00190983
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Gynecologic Oncology Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia, Uterine Neoplasms, Genital Neoplasms, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.
Primary Outcome Measure Information:
Title
Tumor Response
Description
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.
Time Frame
baseline to measured progressive disease (up to 5 years)
Secondary Outcome Measure Information:
Title
Duration of Response
Description
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.
Time Frame
time of initial response until documented tumor progression (up to 5 years)
Title
Progression-Free Survival
Description
The period from study entry until disease progression, death or date of last contact.
Time Frame
baseline until documented tumor progression (up to 5 years)
Title
Overall Survival
Description
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time Frame
baseline until death from any cause (up to 5 years)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Miller, MD
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
Gynecologic Oncology Group 215-854-0770
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial for Patients With Advanced/Recurrent Cervical Cancer
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