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

NCT ID: NCT00113607

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 672 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2010-11-30

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.

Detailed Description

This is a multicenter, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), Phase 3 study comparing the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who were previously treated and for whom first-line platinum-based chemotherapy regimen has failed). Approximately 650 patients will be randomly assigned to 1 of the treatment arms (DOXIL and DOXIL + trabectedin) over 2 years. At the time of randomization, patients will be stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and baseline Eastern Cooperative Oncology Group performance status score (0 to 1 or 2. Safety will be evaluated on the basis of adverse events, clinical laboratory tests, physical examination, vital signs assessment and cardiovascular safety assessment. An interim analysis of overall survival will be performed in conjunction with progression-free survival analysis during the study. Treatment will be continued until disease progression occurred or until patients experienced a confirmed complete response for at least 2 cycles. Continuation of treatment in select individual patients beyond this study end date will be allowed if the investigator determined that the patient is benefiting from treatment, is eligible to receive further therapy, and consents to treatment. If disease progression has not occurred at treatment termination, then disease assessment will continue every 8 weeks until there is evidence of disease progression or death, or until the clinical data cutoff date, or until the start of first subsequent anticancer therapy, whichever is earlier.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DOXIL + trabectedin

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.

Group Type: EXPERIMENTAL

Trabectedin

Intervention Type: DRUG

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

DOXIL

Intervention Type: 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.

Dexamethasone

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

DOXIL

Intervention Type: 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.

Interventions

Trabectedin

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

Intervention Type: DRUG

DOXIL

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.

Intervention Type: DRUG

Dexamethasone

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.

Intervention Type: DRUG

Other Intervention Names

Yondelis; CAELYX

Eligibility 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
• Eastern Cooperative Oncology Group status of not more than 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
• Known clinically relevant central nervous system metastasis

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

PharmaMar

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Mobile, Alabama, United States

Tucson, Arizona, United States

Los Angeles, California, United States

Newport Beach, California, United States

Orange, California, United States

Englewood, Colorado, United States

Stamford, Connecticut, United States

Tampa, Florida, United States

Coeur d'Alene, Idaho, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

St Louis, Missouri, United States

Morristown, New Jersey, United States

New York, New York, United States

Charlotte, North Carolina, United States

Greenville, North Carolina, United States

Winston-Salem, North Carolina, United States

Cleveland, Ohio, United States

Toledo, Ohio, United States

Portland, Oregon, United States

Pittsburgh, Pennsylvania, United States

Greenville, South Carolina, United States

Chattanooga, Tennessee, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Galveston, Texas, United States

Buenos Aires, , Argentina

Mendoza, , Argentina

Sante Fe, , Argentina

Adelaide, , Australia

Bentleigh, , Australia

Douglas, , Australia

St Leonards, , Australia

Toorak Gardens, , Australia

Edegem, , Belgium

Hasselt, , Belgium

Leuven, , Belgium

Wilrijk, , Belgium

Barretos, , Brazil

Belo Horizonte, , Brazil

Cerqueira César, , Brazil

Londrina, , Brazil

Santo André, , Brazil

São Paulo, , Brazil

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Ottawa, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Reneca, , Chile

Santiago, , Chile

Beijing, , China

Guangzhou, , China

Hangzhou, , China

Jinan, , China

Shanghai, , China

Chartres, , France

Paris, , France

Pierre-Bénite, , France

Düsseldorf, , Germany

Heidelberg, , Germany

Jena, , Germany

Karlsruhe, , Germany

Mainz, , Germany

Villingen-Schwenningen, , Germany

Wilhelmshaven, , Germany

Chai Wan, , Hong Kong

Hong Kong, , Hong Kong

Shatin, , Hong Kong

Amsterdam, , Netherlands

Enschede, , Netherlands

Groningen, , Netherlands

Maastricht, , Netherlands

Gdansku, , Poland

Gliwice, , Poland

Krakow, , Poland

Olsztyn, , Poland

Poznan, , Poland

Warszawa Poland, , Poland

Wroclaw, , Poland

Chelyabinsk, , Russia

Moscow, , Russia

Obninsk, Kaluga Region, , Russia

Orenburg, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Singapore, , Singapore

Seoul, , South Korea

Barcelona, , Spain

Girona, , Spain

Guadalajara, , Spain

L'Hospitalet de Llobregat, , Spain

Madrid, , Spain

Marañón, , Spain

Valencia, , Spain

Zaragoza, , Spain

Gothenburg, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

Kaohsiung County, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Birmingham, , United Kingdom

Edinburgh, , United Kingdom

Leicester, , United Kingdom

London, , United Kingdom

Nottingham, , United Kingdom

Poole, , United Kingdom

Sheffield, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Chile; China; France; Germany; Hong Kong; Netherlands; Poland; Russia; Singapore; South Korea; Spain; Sweden; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37407274 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33960681 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22765965 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22541893 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/20516432

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.

http://www.ncbi.nlm.nih.gov/pubmed/22541893

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.

Other Identifiers

ET743-OVA-301

Identifier Type: OTHER

Identifier Source: secondary_id

2004-005276-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR003448

Identifier Type: -

Identifier Source: org_study_id