NCT00653952

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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 1997

Typical duration for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

First QC Date

April 1, 2008

Last Update Submit

April 23, 2010

Conditions

Ovarian Neoplasms

Keywords

Paclitaxel HClCAELYXDOXILOvarian CarcinomaDoxorubicin HCl

Outcome Measures

Primary Outcomes (1)

  • To demonstrate noninferiority with respect to time to progression (TTP) for CAELYX/DOXIL treatment when compared to paclitaxel treatment.

    8 week intervals

Secondary Outcomes (1)

  • Response rates, time to response, duration of response,quality of life assessment, and survival following treatment with either CAELYX or Paclitaxel HCl.

    one year

Study Arms (2)

001

EXPERIMENTAL
Drug: CAELYX

002

ACTIVE COMPARATOR
Drug: Paclitaxel HCl

Interventions

CAELYXDRUG

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

001
Paclitaxel HClDRUG

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

002

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

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

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 7, 2008

Study Start

May 1, 1997

Study Completion

April 1, 2000

Last Updated

April 27, 2010

Record last verified: 2010-04