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:
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
  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:
  • LY231514
  • Alimta

  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
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: 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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on August 26, 2014