An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

NCT00113607 | Completed Phase 3 Results DMC

• 3 other identifiers: CR003448ET743-OVA-3012004-005276-16
• Study Type: interventional
• Target: 672
• Locations: 20 countries
• Sites: 111

Brief Summary

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; Trabectedin; Yondelis; Advanced Relapsed Ovarian Cancer; DOXIL; CAELYX

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS): Independent Radiologist Review

  PFS is defined as the time between randomization and disease progression or death.

  From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

Secondary Outcomes (5)

• Overall Survival

  From the date of randomization until the date of death, as assessed for approximately 3 years

• Objective Response Rate (ORR) - Independent Radiologist Review

  From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years

• Duration of Response: Independent Radiologist Review

  From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years

• Median Area Under Curve (AUC) of Trabectedin.

  Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

• Median Maximum Plasma Concentration (Cmax) of Trabectedin.

  Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

Study Arms (2)

DOXIL + trabectedin

EXPERIMENTAL

Combination arm - Trabectedin + DOXIL: DOXIL 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. patients will be premedicated with 20 mg dexamethasone or its equivalent IV infusion over 30 minutes prior to the DOXIL infusion.

Drug: Trabectedin; Drug: DOXIL; Drug: Dexamethasone

DOXIL

ACTIVE COMPARATOR

Monotherapy arm - DOXIL: 50 mg/m2 IV infusion over 90 minutes every 4 weeks.

Drug: DOXIL

Interventions

Trabectedin DRUG

Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.

Also known as: Yondelis

DOXIL + trabectedin

DOXIL DRUG

Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.

Also known as: CAELYX

DOXIL; DOXIL + trabectedin

Dexamethasone DRUG

Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.

DOXIL + trabectedin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
• Prior treatment with only 1 platinum based chemotherapy regimen
• Eastern Cooperative Oncology Group status of not more than 2
• Progression more than 6 months after the start of initial chemotherapy treatment

You may not qualify if:

• 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
• Known clinically relevant central nervous system metastasis

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PharmaMar: collaborator

Study Sites (111)

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Mobile, Alabama, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Orange, California, United States

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Englewood, Colorado, United States

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Stamford, Connecticut, United States

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Tampa, Florida, United States

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Coeur d'Alene, Idaho, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Morristown, New Jersey, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Greenville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Buenos Aires, Argentina

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Mendoza, Argentina

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Sante Fe, Argentina

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Adelaide, Australia

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Bentleigh, Australia

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Douglas, Australia

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St Leonards, Australia

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Toorak Gardens, Australia

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Edegem, Belgium

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Hasselt, Belgium

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Leuven, Belgium

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Wilrijk, Belgium

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Barretos, Brazil

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Belo Horizonte, Brazil

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Cerqueira César, Brazil

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Londrina, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Reneca, Chile

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Santiago, Chile

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Beijing, China

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Guangzhou, China

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Hangzhou, China

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Jinan, China

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Shanghai, China

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Chartres, France

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Paris, France

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Pierre-Bénite, France

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Düsseldorf, Germany

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Heidelberg, Germany

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Jena, Germany

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Karlsruhe, Germany

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Mainz, Germany

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Villingen-Schwenningen, Germany

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Wilhelmshaven, Germany

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Chai Wan, Hong Kong

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Hong Kong, Hong Kong

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Shatin, Hong Kong

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Amsterdam, Netherlands

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Enschede, Netherlands

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Groningen, Netherlands

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Maastricht, Netherlands

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Gdansku, Poland

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Gliwice, Poland

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Krakow, Poland

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Olsztyn, Poland

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Poznan, Poland

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Warszawa Poland, Poland

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Wroclaw, Poland

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Chelyabinsk, Russia

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Moscow, Russia

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Obninsk, Kaluga Region, Russia

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Orenburg, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Singapore, Singapore

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Seoul, South Korea

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Barcelona, Spain

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Girona, Spain

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Guadalajara, Spain

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Marañón, Spain

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Valencia, Spain

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Zaragoza, Spain

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Gothenburg, Sweden

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Umeå, Sweden

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Uppsala, Sweden

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Kaohsiung County, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Birmingham, United Kingdom

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Edinburgh, United Kingdom

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Leicester, United Kingdom

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London, United Kingdom

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Nottingham, United Kingdom

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Poole, United Kingdom

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Sheffield, United Kingdom

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Related Publications (4)

• Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

  PMID: 37407274 DERIVED

• Jones RL, Herzog TJ, Patel SR, von Mehren M, Schuetze SM, Van Tine BA, Coleman RL, Knoblauch R, Triantos S, Hu P, Shalaby W, McGowan T, Monk BJ, Demetri GD. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med. 2021 Jun;10(11):3565-3574. doi: 10.1002/cam4.3903. Epub 2021 May 7.

  PMID: 33960681 DERIVED

• Krasner CN, Poveda A, Herzog TJ, Vermorken JB, Kaye SB, Nieto A, Claret PL, Park YC, Parekh T, Monk BJ. Patient-reported outcomes in relapsed ovarian cancer: results from a randomized Phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD alone. Gynecol Oncol. 2012 Oct;127(1):161-7. doi: 10.1016/j.ygyno.2012.06.034. Epub 2012 Jul 2.

  PMID: 22765965 DERIVED

• Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Park YC, Parekh TV, Poveda AM. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: overall survival analysis. Eur J Cancer. 2012 Oct;48(15):2361-8. doi: 10.1016/j.ejca.2012.04.001. Epub 2012 Apr 26.

  PMID: 22541893 DERIVED

Related Links

• Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Lisyanskaya AS, Makhson AN, Rolski J, Gorbounova VA, Ghatage P, Bidzinski M, Shen K, Ngan HY, Vergote IB, Nam JH, Park YC, Lebedinsky CA, Poveda AM.
• Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Park YC, Parekh TV, Poveda AM. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: Overall survival analysis.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Trabectedin; liposomal doxorubicin; Dexamethasone

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Director Clinical Research Medical Leader
• Organization: Janssen R&D US

908 704 5779

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2005
• First Posted: June 10, 2005
• Study Start: April 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: August 23, 2013

Record last verified: 2014-06

Locations

GB (7); CA (5); CL (2); BR (6); RU (6); US (28); BE (4); CN (5); DE (7); NL (4); KR (1); AU (5); SG (1); SE (3); PL (7); TW (3); ES (8); FR (3); AR (3); HK (3)