A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461786
• Other study ID #: 8364
• Secondary ID: H3E-US-JMGP
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2007
• Last updated: December 1, 2009
• Start date: September 2004
• Est. completion date: May 2008

Study information

• Verified date: December 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• pemetrexed
900 mg/m2, intravenous (IV), every 21 days, until disease progression

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response		baseline to measured progressive disease (up to 44 months)	No
Secondary	Number of Participants With Adverse Events by Grade		every 21-day cycle up to 5 year follow-up	Yes
Secondary	Duration of Response		time of initial response until documented tumor progression (up to 44 months)	No
Secondary	Progression-Free Survival		baseline until documented tumor progression (up to 44 months)	No
Secondary	Overall Survival		baseline until death from any cause up to 5-year follow-up	No

External Links

•   Lilly Clinical Trial Registry