Status:
TERMINATED
CAELYX Versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Sequus Pharmaceuticals
ALZA
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 chemothe...
Detailed Description
This is a randomized, open-label, comparative study of CAELYX versus Paclitaxel HCl in the treatment of patients with epithelial ovarian carcinoma following failure of first line chemotherapy with a p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2000
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00653952
Start Date
May 1 1997
End Date
April 1 2000
Last Update
April 27 2010
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