Clinical trial NCT00113607: An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
Trabectedin
Yondelis
Advanced Relapsed Ovarian Cancer
DOXIL
CAELYX
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
First posted: 2005-06-10
Enrollment: 672
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-Free Survival (PFS): Independent Radiologist Review
timeFrame: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: From the date of randomization until the date of death, as assessed for approximately 3 years
measure: Objective Response Rate (ORR) - Independent Radiologist Review
timeFrame: From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years
measure: Duration of Response: Independent Radiologist Review
timeFrame: 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
measure: Median Area Under Curve (AUC) of Trabectedin.
timeFrame: 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
measure: Median Maximum Plasma Concentration (Cmax) of Trabectedin.
timeFrame: 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
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Orange
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Coeur D Alene
country: United States
state: Idaho
city: Louisville
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state: Kentucky
city: New Orleans
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state: Louisiana
city: Boston
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state: Massachusetts
city: Minneapolis
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state: Minnesota
city: Saint Louis
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state: Missouri
city: Morristown
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state: New Jersey
city: New York
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state: New York
city: Charlotte
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state: North Carolina
city: Greenville
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state: North Carolina
city: Winston Salem
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state: North Carolina
city: Cleveland
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state: Ohio
city: Toledo
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state: Ohio
city: Portland
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state: Oregon
city: Pittsburgh
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state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Chattanooga
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state: Tennessee
city: Nashville
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state: Tennessee
city: Dallas
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state: Texas
city: Galveston
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state: Texas
city: Buenos Aires
country: Argentina
city: Mendoza
country: Argentina
city: Sante Fe
country: Argentina
city: Adelaide
country: Australia
city: Bentleigh
country: Australia
city: Douglas
country: Australia
city: St Leonards
country: Australia
city: Toorak Gardens
country: Australia
city: Edegem
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Wilrijk
country: Belgium
city: Barretos
country: Brazil
city: Belo Horizonte
country: Brazil
city: Cerqueira Cesar
country: Brazil
city: Londrina
country: Brazil
city: Santo Andre
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Reneca
country: Chile
city: Santiago
country: Chile
city: Beijing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Jinan
country: China
city: Shanghai
country: China
city: Chartres
country: France
city: Paris
country: France
city: Pierre Benite Cedex
country: France
city: Düsseldorf
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Mainz
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Wilhelmshaven
country: Germany
city: Chai Wan
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Sha Tin
country: Hong Kong
city: Seoul
country: Korea, Republic of
city: Amsterdam
country: Netherlands
city: Enschede
country: Netherlands
city: Groningen
country: Netherlands
city: Maastricht
country: Netherlands
city: Gdansku
country: Poland
city: Gliwice
country: Poland
city: Krakow
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Warszawa Poland
country: Poland
city: Wroclaw
country: Poland
city: Chelyabinsk
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk, Kaluga Region
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Singapore
country: Singapore
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Guadalajara
country: Spain
city: L'Hospitalet De Llobregat
country: Spain
city: Madrid
country: Spain
city: Maranon
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Göteborg
country: Sweden
city: Umeå
country: Sweden
city: Uppsala
country: Sweden
city: Kaohsiung County
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Birmingham
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Poole
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.