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An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
This study is ongoing, but not recruiting participants.
First Received: June 9, 2005   Last Updated: August 10, 2009   History of Changes
Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar S.A.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00113607
  Purpose

This study tests the safety and effectiveness of a YONDELIS® (trabectedin) and DOXIL/CAELYX (herein referred to as DOXIL) combination to DOXIL alone.


Condition Intervention Phase
Ovarian Cancer
Drug: DOXIL
Drug: trabectedin + DOXIL
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • progression-free survival as assessed by independent radiology review [ Time Frame: every 8 weeks after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: every 8 weeks for first 2 years then every 3 months thereafter ] [ Designated as safety issue: Yes ]
  • response rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
  • safety [ Time Frame: weekly until treatment is terminated ] [ Designated as safety issue: Yes ]
  • pharmacokinetics [ Time Frame: weekly during cycle 1 & 2 ] [ Designated as safety issue: No ]

Study Start Date: April 2005
Estimated Study Completion Date: May 2011
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: trabectedin + DOXIL
Trabectedin 1.1 mg/m² as a 3 hour infusion + DOXIL 30 mg/m² every 3 weeks
002: Active Comparator Drug: DOXIL
50 mg/m² every 4 weeks

Detailed Description:

This is a multicenter, open-label, randomized, Phase 3 study comparing the combination of Doxil, 30mg/m2, administered as a 90-minute infusion followed by trabectedin, 1.1 mg/m2 3-hour infusion, every 3 weeks with DOXIL, 50 mg/m2 as a 90-minute infusion every 4 weeks, in previously treated patients with advanced ovarian cancer for whom first-line platinum-based chemotherapy regimen has failed. The purpose of this research study is to determine if the combination of trabectedin and DOXIL is better at improving progression free survival over DOXIL alone in patients with relapsed advanced ovarian cancer. Additional comparisons between the two treatment groups include: overall survival, measurement of disease progression, response rate, (how much your tumor shrinks in response to the drug) safety, pharmacokinetics (measuring the amount of drug in your body), quality of life, and optional measurement of circulating tumor cells if present. Patients may receive either a combination of trabectedin and DOXIL (Group A) or DOXIL alone (Group B). If you are in Group A you will receive dexamethasone followed by Trabectedin 1.1 mg/m² as a 3 hour infusion + DOXIL 30 mg/m² every 3 weeks as long as you are responding to treatment. If you are in Group B you will receive DOXIL 50 mg/m2 every 4 weeks as long as you are responding to treatment.

  Eligibility

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

Inclusion Criteria:

  • Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
  • Prior treatment with only 1 platinum based chemotherapy regimen
  • ECOG status <=2
  • Progression more than 6 months after the start of initial chemotherapy treatment

Exclusion Criteria:

  • Treatment with more than 1 prior chemotherapy regimen
  • Progression within 6 months after starting initial chemotherapy
  • Prior exposure to anthracyclines
  • Unwilling or unable to have central venous catheter
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113607

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar S.A.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Director )
Study ID Numbers: CR003448, ET743-OVA-301
Study First Received: June 9, 2005
Last Updated: August 10, 2009
ClinicalTrials.gov Identifier: NCT00113607     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Trabectedin
Yondelis
Ovarian cancer

Study placed in the following topic categories:
Ecteinascidin 743
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Doxorubicin
Genital Diseases, Female
Anti-Bacterial Agents
Ovarian Cancer
Antineoplastic Agents, Alkylating
Endocrinopathy
Alkylating Agents
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ecteinascidin 743
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009