A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal 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:
NCT00461786
First received: April 16, 2007
Last updated: December 1, 2009
Last verified: December 2009
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Purpose
The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Peritoneal Cancer |
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, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma |
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 44 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants With Adverse Events by Grade [ Time Frame: every 21-day cycle up to 5 year follow-up ] [ Designated as safety issue: Yes ]
- Duration of Response [ Time Frame: time of initial response until documented tumor progression (up to 44 months) ] [ Designated as safety issue: No ]
- Progression-Free Survival [ Time Frame: baseline until documented tumor progression (up to 44 months) ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: baseline until death from any cause up to 5-year follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | September 2004 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pemetrexed |
Drug: pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Names:
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer
- Measurable disease
- Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel
- Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
- Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e., any active phase III GOG protocol for the same patient population)
Exclusion Criteria:
- Patients who have had prior therapy with pemetrexed
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- Patients who have received radiation to more than 25% of marrow
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461786
Locations
| United States, Pennsylvania | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Philadelphia, Pennsylvania, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Gynecologic Oncology Group
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00461786 History of Changes |
| Other Study ID Numbers: | 8364, H3E-US-JMGP |
| Study First Received: | April 16, 2007 |
| Results First Received: | October 13, 2008 |
| Last Updated: | December 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases 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