A Study Comparing the Combination of Doxil and Yondelis, to Doxil Alone for Subjects With Ovarian Cancer - Full Text View

A Study Comparing the Combination of Doxil and Yondelis, to Doxil Alone for Subjects With Ovarian Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00113607

Purpose

The purpose of this research study is to determine if the combination of Yondelis and Doxil is better at improving overall survival over Doxil alone in subjects with relapsed advanced ovarian cancer.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Yondelis Drug: DOXIL	Phase III

MedlinePlus related topics:

Cancer Ovarian Cancer

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Ecteinascidin 743

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Official Title:	An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of Doxil/Caelyx and Yondelis to Doxil/Caelyx Alone in Subjects With Advanced Relapsed Ovarian Cancer

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

Primary Outcome Measures:

The primary objective of the study is to demonstrate that the combination of YONDELIS™ (trabectedin) for intravenous infusion + DOXIL®/CAELYX® improves overall survival over DOXIL alone in the management of ovarian cancer in second line therapy. [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]

Estimated Enrollment:	650
Study Start Date:	April 2005
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DOXIL, 30mg/m2 follwed by YONDELIS, 1.1 mg/m2 every q3wk	Drug: Yondelis 1.1 mg/m2 q3wk Drug: DOXIL 30mg/m2 followed by YONDELIS, 1.1 mg/m2 q3wk
2: Experimental DOXIL, 50 mg/m2 q4wk	Drug: DOXIL DOXIL 50mg/m2 q4wk

Eligibility

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

Criteria

Inclusion Criteria:

Female, age 18 or older
Histologically proven epithelial ovarian cancer
Prior treatment with only 1 platinum-based chemotherapy regimen
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Recurrence or progression more than six months after the beginning of the initial line of platinum-based chemotherapy for ovarian cancer

Exclusion Criteria:

Subjects treated with more than 1 prior chemotherapy regimen (including adjuvant therapy)
Refractory disease
Isolated rise in CA-125 without documented radiological evidence of disease progression

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113607

Show 152 Study Locations

Sponsors and Collaborators

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

PharmaMar

Investigators


Investigator:	Johnson & Johnson Pharmaceutical Research & Development, LLC

More Information

website containing information for how to contact a participating site for this ovarian cancer study This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	Johnson and Johnson Pharmaceutical Research and Development ( Eliel Bayever, Sr. Director Clinical Research )
Study ID Numbers:	ET743-OVA-301, ET743-OVA-301
First Received:	June 9, 2005
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00113607
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Ovarian

Cancer

Advanced Relapsed Ovarian Cancer

Study placed in the following topic categories:

Ecteinascidin 743

Genital Diseases, Female

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Endocrinopathy

Ovarian Diseases

Doxorubicin

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Antineoplastic Agents, Alkylating

Antibiotics, Antineoplastic

Alkylating Agents

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on October 03, 2008