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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


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
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