A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal 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. Identifier: NCT00461786
Recruitment Status : Completed
First Posted : April 18, 2007
Results First Posted : August 24, 2009
Last Update Posted : December 4, 2009
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cancer Drug: pemetrexed Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 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, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma
Study Start Date : September 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pemetrexed Drug: pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Names:
  • LY231514
  • Alimta

Primary Outcome Measures :
  1. Tumor Response [ Time Frame: baseline to measured progressive disease (up to 44 months) ]

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events by Grade [ Time Frame: every 21-day cycle up to 5 year follow-up ]
  2. Duration of Response [ Time Frame: time of initial response until documented tumor progression (up to 44 months) ]
  3. Progression-Free Survival [ Time Frame: baseline until documented tumor progression (up to 44 months) ]
  4. Overall Survival [ Time Frame: baseline until death from any cause up to 5-year follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00461786

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
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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00461786     History of Changes
Other Study ID Numbers: 8364
First Posted: April 18, 2007    Key Record Dates
Results First Posted: August 24, 2009
Last Update Posted: December 4, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors