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

This study has been terminated.
(Poor accrual)
Sponsor:
Collaborators:
Sequus Pharmaceuticals
ALZA
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00653952
First received: April 1, 2008
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
Drug: CAELYX
Drug: Paclitaxel HCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • To demonstrate noninferiority with respect to time to progression (TTP) for CAELYX/DOXIL treatment when compared to paclitaxel treatment. [ Time Frame: 8 week intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rates, time to response, duration of response,quality of life assessment, and survival following treatment with either CAELYX or Paclitaxel HCl. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: May 1997
Study Completion Date: April 2000
Arms Assigned Interventions
Experimental: 001 Drug: CAELYX
Dose of 50 mg/m2 by i.v. infusion over 1 hour every 28 days for up to 1 year
Active Comparator: 002 Drug: Paclitaxel HCl
Dose of 175 mg/m2 by i.v. infusion over 3 hours starting on Day 1 of a 21-day cy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653952

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sequus Pharmaceuticals
ALZA
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: DIRECTOR MEDICAL LEADER, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00653952     History of Changes
Other Study ID Numbers: CR004369, DOXIL-CAN-301
Study First Received: April 1, 2008
Last Updated: April 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Paclitaxel HCl
CAELYX
DOXIL
Ovarian Carcinoma
Doxorubicin HCl

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014