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Ovarian

A Phase III, Randomized, Open-Label, Comparative Study of CAELYX versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Unique Data Set IDOvarian_Johnson_1997_140
DownloadableYes
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Data ProviderJanssenTotal Study Enrolled Patients217Comparator (Control) Arm Enrolled Patients108RandomizationYesClinicalTrial.gov IDN/AClinicalTrial.gov URLN/A
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeOther

Clinical Trial Title

A Phase III, Randomized, Open-Label, Comparative Study of CAELYX versus Paclitaxel HCl in Patients With Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Trial Summary and Conditions

This was a randomized, open-label, comparative study of DOXIL and Paclitaxel in the treatment of subjects with epithelial ovarian carcinoma following failure of first-line chemotherapy with a platinum-based regimen. Subjects entering the trial were stratified by platinum-sensitivity and bulky disease. Protocol-eligible subjects with measurable disease, who had received no more than 1 prior platinum-based regimen, were randomized in a 1:1 ratio within each stratum to receive either a 1-hour intravenous infusion of DOXIL 50 mg/m2 every 28 days or paclitaxel 175 mg/m2 as a 3-hour infusion every 21 days. Subjects were to have been treated for up to 1 year. Subjects underwent appropriate radiologic imaging (x-ray, CT scan, MRI) to document baseline disease, as well as a chest x-ray and an assessment of left ventricular ejection fraction (LVEF) by multiple-gated acquisition scan within 30 days prior to the first dose of study drug. Subjects were followed weekly for hematologic toxicities. Radiologic imaging was repeated every 7 to 8 weeks to assess disease status. Subjects who achieved complete or partial response were reevaluated 4 weeks later to confirm the initial observation of response. All subjects were to have been followed for a minimum of 1 year for survival and disease progression. The study was closed to new subjects on 31 August 1999, because of poor accrual after Taxol (paclitaxel HCl) was approved for use in combination with platinum-based therapy for the first-line treatment of ovarian cancer by the European Agency for the Evaluation of Medicinal Products.

Data Summary

Control arm (Paclitaxel HCl) data files include analysis data on safety, efficacy, demographic, and baseline disease characteristics.

Study Objectives

The objective of this study was to compare the efficacy and safety of DOXIL (CAELYX) versus paclitaxel HCl in subjects with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy.

Outcome Measures

The primary efficacy endpoint of this study was time to progression defined as the time from the first study drug administration until documented disease progression or death due to underlying malignancy. The key secondary efficacy endpoint of this study was the response rate defined as the proportion of subjects with at least a durable response (CR or PR).

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Protocol-OVC-30-57.pdf

CRF: BlankCRF-OVC-30-57.pdf

DATA DICTIONARY: DataDef_OVC_30_57.xls

DATA (COMPARATOR ARM): Datasets-OVC-30-57.zip