A Trial for Patients With Advanced/Recurrent Cervical Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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:
|
Cervical Intraepithelial Neoplasia Genital Neoplasms, Female Neoplasms Carcinoma Carcinoma in Situ Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Neoplasms |
Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015