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

NCT00653952TerminatedPHASE3INTERVENTIONAL

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.

Key Facts

Lead Sponsor

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

Enrollment

220

Start Date

1997-05-01

Study Type

INTERVENTIONAL

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

Interventions

CAELYXPaclitaxel HCl

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: 8 week intervals

Secondary Outcomes

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

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.