A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.

Launched by ELI LILLY AND COMPANY · Sep 12, 2005

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• 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.