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

Phase 3
18 Years
Not Enrolling
Ovarian Neoplasms

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Trial Information

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

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 platinum-based regimen. Patients entering the trial will be stratified
prospectively for platinum-sensitivity and bulky disease and analyzed retrospectively for
prior anthracycline therapy. Protocol-eligible patients, with measurable disease, who have
received no more than one prior regimen, which was platinum-based, will be randomized to
receive either a one-hour intravenous infusion of CAELYX, 50 mg/m2 every 28 days, or
Paclitaxel HCl, 175 mg/m2 as a 3 hour infusion every 21 days. Patients will be treated for
up to one year. It is suggested that responding patients receive at least 6 cycles of
treatment. Patients with ongoing clinical benefit may continue study drug upon approval of
the sponsor as long as it is in the patient's interest and in the absence of severe
toxicity. It is suggested that patients exhibiting a complete response (CR) receive 2
subsequent cycles of treatment. Patients exhibiting partial response (PR) may continue to
receive study drug as long as therapeutic benefit is being derived but it is suggested that
they receive at least 3 subsequent cycles of study drug. Patients will undergo appropriate
radiological 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 MUGA scan within 30
days prior to the first dose of study drug. Patients will be followed weekly for
hematological toxicities. Radiological imaging will be repeated every 7-8 weeks to assess
disease status. Patients who achieve complete or partial response will be reevaluated 4
weeks later to confirm the initial observation of response. All patients will be followed
for a minimum of one year for disease progression and survival. LVEF will be assessed by
MUGA scan at baseline, when the cumulative anthracycline dose reaches 300 mg/m2 (500 mg/m2
epirubicin), and after every 2 cycles of CAELYX thereafter. Endomyocardial biopsy is
recommended for patients who have received > 400 mg/m2 of CAELYX alone or a cumulative
anthracycline dose of > 550 mg/m2 (including CAELYX; 900 mg/m2 if epirubicin). [NOTE: This
study was initiated on 7-May-1997. Due to poor accrual, the study enrollment was terminated
on 31-Aug-1999. Patients were followed until study completion on 12-Apr-2000. During the
preparation of the study report (beginning in May 2003), the sites were re-queried for
clarification of safety and survival data.]

DOXIL, dose of 50 mg/m2 by i.v. infusion over 1 hour every 28 days for up to 1 year.
Paclitaxel, dose of 175 mg/m2 by i.v. infusion over 3 hours starting on Day 1 of a 21-day
cycle for up to 1 year.

Inclusion Criteria:

- 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

- Adequate renal creatinine (<2.5 mg/dL (<220 ╬╝mol/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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

8 week intervals

Safety Issue:


Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

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


United States: Food and Drug Administration

Study ID:




Start Date:

May 1997

Completion Date:

April 2000

Related Keywords:

  • Ovarian Neoplasms
  • Paclitaxel HCl
  • Ovarian Carcinoma
  • Doxorubicin HCl
  • Neoplasms
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial