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A Phase 3, Randomized, Open-Label, Comparative Study of DOXIL/CAELYX Versus Topotecan HCl in Patients with Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Unique Dataset IDSTUDY_SEQUUS-30-49
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Data ProviderJanssenTotal Study Enrolled Patients481Comparator (Control) Arm Enrolled Patients241RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyDataset TypeOther

Clinical Trial Title

A Phase 3, Randomized, Open-Label, Comparative Study of DOXIL/CAELYX Versus Topotecan HCl in Patients with Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy

Trial Summary and Conditions

This was a Phase 3, parallel-group, randomized, multicenter, open-label, active-controlled study of women with epithelial ovarian carcinoma whose disease did not respond to or recurred after treatment with first-line chemotherapy with a platinum-based regimen. They had measurable disease and a Karnofsky performance status (KPS) of 60% or higher. Subjects received either a 1-hour i.v. infusion of DOXIL, 50 mg/m2 every 4 weeks, or topotecan, 1.5 mg/m2 per day as a 30-minute i.v. infusion for 5 consecutive days, repeated every 3 weeks. The dose of DOXIL used (50 mg/m2 via 1-hour i.v. infusion every 4 weeks) was selected on the basis of the results of Phase 1 and Phase 2 studies, which indicated that this dose had meaningful clinical activity and was well tolerated. Topotecan was administered at the FDA-approved dose and frequency for treatment of ovarian cancer. To obtain 370 evaluable subjects, up to 460 subjects were to have been enrolled in the study. Subjects were randomized to treatment in a 1:1 ratio stratified by platinum sensitivity and the presence or absence of bulky disease. According to the standards of care for this patient population at many participating sites, subjects could discontinue study treatment and be considered to have completed the protocol at the discretion of the investigator or subject after 6 months (6 cycles of DOXIL, 8 cycles of topotecan). Subjects with ongoing clinical benefit were able to continue study drug until disease progression upon approval of the sponsor. All randomized subjects who met enrollment criteria and received at least 2 cycles of study drug were considered evaluable for efficacy. Subjects who withdrew from the study were not replaced.

Data Summary

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

Study Objectives

The primary objective of this study was to compare the efficacy and safety of DOXIL to those of topotecan in subjects with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. It was designed as a non-inferiority study. The objective of the post-study long-term follow-up analysis is to compare DOXIL versus topotecan HCl in terms of survival and PFS when approximately 90% of subjects have either died or are lost to follow-up.

Outcome Measures

The primary efficacy endpoint of this study was overall survival time defined as the time from the start of study drug administration to death. The secondary efficacy endpoint of this study was progression-free survival defined as the time from the first day of study drug dosing to the documented disease progression or death due to any cause while the subject was on study or during the long-term follow-up period.

Available Downloads:

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

PROTOCOL: Protocol-OVC-30-49.pdf

CRF: BlankCRF-OVC-30-49.pdf

DATA DICTIONARY: DataDef_OVC_30_49.xls