Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01846611




Registration number
NCT01846611
Ethics application status
Date submitted
1/05/2013
Date registered
3/05/2013
Date last updated
1/04/2019

Titles & IDs
Public title
A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Scientific title
A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Secondary ID [1] 0 0
ET743OVC3006
Secondary ID [2] 0 0
CR100983
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Peritoneal Neoplasms 0 0
Fallopian Tube Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trabectedin
Treatment: Drugs - DOXIL
Treatment: Drugs - Dexamethasone
Treatment: Drugs - DOXIL

Experimental: Arm A: trabectedin + DOXIL - Participants will receive DOXIL 30 millgram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3hours, every 3 weeks. Participants will be pretreated with 20 mg dexamethasone IV (or the IV equivalent) approximately 30 minutes before DOXIL study drug. As of Amendment 6, treatment with trabectedin will be discontinued for participants on treatment with trabectedin and no new participants will receive trabectedin. Participants who, in the opinion of the investigator, are deriving clinical benefit may continue treatment with single-agent DOXIL as per the local standard of care.

Active comparator: Arm B: DOXIL - Participants will receive DOXIL, 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes every 4 weeks.


Treatment: Drugs: Trabectedin
1.1 mg/m\^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.

Treatment: Drugs: DOXIL
30 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.

Treatment: Drugs: Dexamethasone
20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.

Treatment: Drugs: DOXIL
50 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 4.3 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 4.3 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 4.3 years

Eligibility
Key inclusion criteria
* Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for >= 6 months after the last dose
* Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a response
* Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs >=9 months from the first dose)
* Evidence of measurable disease at screening as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
* Participants no longer need to be able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
* Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA 1/2 status at screening, a blood sample will be collected to determine the status with the results available prior to randomization
* Laboratory values within protocol -defined parameters
* Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or 2D-ECHO within normal limits for the institution
* Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
* Have a negative urine or serum pregnancy test at screening
* Agrees to protocol-defined use of effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of ovarian carcinoma with mucinous histology
* Had more than 2 prior lines of systemic therapy. Maintenance therapies and hormonal therapies are not considered additional lines of therapy
* Participants who had a prior exposure to trabectedin or hypersensitivity to any of the excipients will not be excluded from receiving single-agent Doxil
* Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
* Participants unwilling or unable to have a central venous catheter placed will not be excluded from receiving single-agent Doxil
* Pregnant or breast-feeding
* Would receive study treatment within 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy; use an invasive investigational device; or is currently enrolled in an investigational study
* History of another invasive malignancy (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for >=5 years, or a non - invasive malignancy requiring ongoing therapy
* Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their excipients
* Known history of central nervous system metastasis
* Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)
* Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
* Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
* Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2018
Sample size
Target
Accrual to date
Final
581
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Ballarat
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Gosford
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Subiaco
Recruitment hospital [7] 0 0
- Toorak Gardens
Recruitment hospital [8] 0 0
- Townsville
Recruitment hospital [9] 0 0
- Wodonga
Recruitment hospital [10] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Gosford
Recruitment postcode(s) [5] 0 0
- Parkville
Recruitment postcode(s) [6] 0 0
- Subiaco
Recruitment postcode(s) [7] 0 0
- Toorak Gardens
Recruitment postcode(s) [8] 0 0
- Townsville
Recruitment postcode(s) [9] 0 0
- Wodonga
Recruitment postcode(s) [10] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
China
State/province [33] 0 0
Guangzhou
Country [34] 0 0
China
State/province [34] 0 0
Jinan
Country [35] 0 0
China
State/province [35] 0 0
Shanghai
Country [36] 0 0
China
State/province [36] 0 0
Shenyang
Country [37] 0 0
Israel
State/province [37] 0 0
Beer Sheva
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Holon
Country [40] 0 0
Israel
State/province [40] 0 0
Jerusalem
Country [41] 0 0
Israel
State/province [41] 0 0
Kfar Saba
Country [42] 0 0
Israel
State/province [42] 0 0
Petah Tikva
Country [43] 0 0
Israel
State/province [43] 0 0
Ramat-Gan
Country [44] 0 0
Israel
State/province [44] 0 0
Rehovot
Country [45] 0 0
Israel
State/province [45] 0 0
Tel Aviv
Country [46] 0 0
Israel
State/province [46] 0 0
Zerifin
Country [47] 0 0
New Zealand
State/province [47] 0 0
Auckland
Country [48] 0 0
New Zealand
State/province [48] 0 0
Wellington
Country [49] 0 0
Poland
State/province [49] 0 0
Bydgoszcz
Country [50] 0 0
Poland
State/province [50] 0 0
Gdansk
Country [51] 0 0
Poland
State/province [51] 0 0
Lublin
Country [52] 0 0
Poland
State/province [52] 0 0
Poznan
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Arkhangelsk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Chelyabinsk
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Ivanovo
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Kirov
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Krasnodar
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Moscow N/a
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Nalchik
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Nizhniy Novgorod
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Nizhny Novgorod
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Omsk
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Orenburg
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Pyatigorsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Ryazan
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Saint Petersburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Saint-Petersburg,
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Sochi
Country [71] 0 0
Russian Federation
State/province [71] 0 0
St Petersburg
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Ufa
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Yaroslavl
Country [74] 0 0
South Africa
State/province [74] 0 0
Amanzimtoti
Country [75] 0 0
South Africa
State/province [75] 0 0
Cape Town
Country [76] 0 0
South Africa
State/province [76] 0 0
Durban
Country [77] 0 0
South Africa
State/province [77] 0 0
Johannesburg
Country [78] 0 0
South Africa
State/province [78] 0 0
Port Elizabeth
Country [79] 0 0
South Africa
State/province [79] 0 0
Pretoria
Country [80] 0 0
Switzerland
State/province [80] 0 0
Bern
Country [81] 0 0
Switzerland
State/province [81] 0 0
Zurich
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Bebington
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Glasgow
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Guilford
Country [85] 0 0
United Kingdom
State/province [85] 0 0
London
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Maidstone
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Manchester
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Plymouth
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PharmaMar
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.
Trial website
https://clinicaltrials.gov/study/NCT01846611
Trial related presentations / publications
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.
Monk BJ, Herzog TJ, Wang G, Triantos S, Maul S, Knoblauch R, McGowan T, Shalaby WSW, Coleman RL. A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer. Gynecol Oncol. 2020 Mar;156(3):535-544. doi: 10.1016/j.ygyno.2019.12.043. Epub 2020 Jan 8.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01846611