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
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 May 19, 2013