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

NCT00653952 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2010-04-27

No results posted yet for this study

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.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

CAELYX

Dose of 50 mg/m2 by i.v. infusion over 1 hour every 28 days for up to 1 year

DRUG

Paclitaxel HCl

Dose of 175 mg/m2 by i.v. infusion over 3 hours starting on Day 1 of a 21-day cy

Sponsors & Collaborators

  • Sequus Pharmaceuticals

    collaborator INDUSTRY

  • ALZA

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Completion
2000-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00653952 on ClinicalTrials.gov