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
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | Gynecologic Oncology Group |
United States,
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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