Status:
COMPLETED
A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.
Lead Sponsor:
Eli Lilly and Company
Conditions:
Genital Neoplasms, Female
Fallopian Tube Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This trial compares two chemotherapy agents for the treatment of recurrent ovarian, fallopian or primary peritoneal cancer in patients that have received and are no longer responding to Platinum based...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All patients must have a documented pathologic diagnosis of epithelial ovarian (FIGO Stage I-IV), Fallopian tube or primary peritoneal carcinoma
- Patients must have received platinum-based, first-line chemotherapy but no more than one additional prior chemotherapy regimen. Patients must have recovered from the acute side effects of prior chemotherapy prior to enrollment in this trial.
- Patients must be considered to have platinum resistant disease based on the most recent platinum-based regimen given, i.e., have had a treatment-free interval in response to platinum of less than six months, or have progressed during platinum-based therapy
- Presence of measurable disease or CA-125 \> or = to 100 on two separate occasions at least one week apart is required for this study
- Patient must have a Zubrod Performance Status of 0, 1 or 2
- Exclusion
- Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who have subsequently developed invasive adenocarcinoma are eligible.
- Patients who are currently undergoing abdominal or pelvic radiation therapy or patients who have received prior abdominal or pelvic radiation therapy are excluded.
- Patients with unstable angina or who have had a heart attack within the past six months are not eligible to participate.
- Patients who have received prior Gemzar or Doxil therapy are ineligible.
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00191607
Start Date
July 1 2002
End Date
November 1 2005
Last Update
January 26 2007
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis, Missouri, United States, 63110