CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

• Status: Terminated
• Trial end date: 2000-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to compare the efficacy and safety of CAELYX versus Paclitaxel HCl in patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. The primary endpoint is time to progression (TTP) following treatment with either CAELYX or Paclitaxel HCl; the secondary endpoints are response rates, time to response, duration of response,quality of life assessment, and survival following treatment with either CAELYX or Paclitaxel HCl. Up to a total of 438 protocol-eligible patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy will be enrolled in order to obtain 350 evaluable patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: ALZA; Sequus Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically proven (i.e., not borderline) epithelial ovarian carcinoma

• Measurable disease

• Recurrence of disease or disease progression indicative of failure of first-line platinum-based chemotherapy

• Disease-free from prior malignancies for >5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

• Adequate renal creatinine (<2.5 mg/dL (<220 μmol/L)) & liver function (aspartate amino transferase (AST) and alanine amino transferase (ALT) <2 x upper limit of normal, alkaline phosphatase <2.0 x upper limit of normal, except if attributed to tumor, and bilirubin < upper limit of normal)

Exclusion Criteria:

• Pregnant or breast feeding

• Life expectancy of <3 months

• Prior radiation therapy to more than one-third of hematopoietic sites within 30 days prior to first dose of study drug

• Prior therapy with DOXIL or paclitaxel

• Prior chemotherapy within 28 days of first dose of study drug (or 42 days if subject has received a nitrosourea or mitomycin)

• Treated with high dose therapy supported by bone marrow or peripheral stem cell transplantation at any time