Ovarian Cancer Clinical Trial

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

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.

View Full Description

Full Description

This is a randomized (individuals assigned to study treatment by chance), open - label (identity of assigned study drug will be known), active - controlled study in adult female patients with platinum-sensitive advanced - relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum - based chemotherapy. Approximately 670 participants will be enrolled. Patients will be stratified by 4 criteria defined in the protocol and randomly assigned in a 1:1 ratio to the trabectedin+DOXIL combination therapy group (Arm A) or to the DOXIL (pegylated liposomal doxorubicin) monotherapy group (Arm B). During the treatment phase, patients will receive study drug infusions according to 21 - day cycles in Arm A and 28 - day cycles in Arm B. Treatment will continue until the occurrence of disease progression or unacceptable treatment toxicity, or until 2 cycles after assessment of a complete response (CR). Efficacy assessments will be evaluated using Response Evaluation Criteria in Solid Tumors. Disease assessments, including assessments for patients who discontinue treatment for reasons other than disease progression, will be performed until disease progression, the start of subsequent anticancer therapy, withdrawal of consent, or the clinical cutoff date. Collection of survival status will continue until at least 514 deaths have been observed or until the clinical data cutoff date. Serial pharmacokinetic (PK) samples will be collected in a subset of patients who voluntarily consent to the PK portion of the study. Safety will be monitored throughout the study. An interim analysis of overall survival (OS) will be performed after approximately 308 participants have died. The final analysis of OS will occur when approximately 514 deaths have been observed or until the clinical cutoff date. As of Amendment 6, no new participants will be randomized to study treatment, and treatment with trabectedin should be immediately discontinued for participants assigned to Arm A (trabectedin+DOXIL). All study participants (Arm A or Arm B) currently on study 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.

View Eligibility Criteria

Eligibility Criteria

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

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 is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

581

Study ID:

NCT01846611

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You


Birmingham Alabama, , United States

Phoenix Arizona, , United States

Scottsdale Arizona, , United States

Sedona Arizona, , United States

Tucson Arizona, , United States

Hot Springs Arkansas, , United States

Greenbrae California, , United States

La Jolla California, , United States

Los Angeles California, , United States

Orange California, , United States

Sacramento California, , United States

Englewood Colorado, , United States

New Britain Connecticut, , United States

New Haven Connecticut, , United States

Stamford Connecticut, , United States

Fort Myers Florida, , United States

Jacksonville Florida, , United States

Miami Florida, , United States

Saint Petersburg Florida, , United States

Sarasota Florida, , United States

Tampa Florida, , United States

Atlanta Georgia, , United States

Savannah Georgia, , United States

Chicago Illinois, , United States

Park Ridge Illinois, , United States

Indianapolis Indiana, , United States

Louisville Kentucky, , United States

Covington Louisiana, , United States

New Orleans Louisiana, , United States

Scarborough Maine, , United States

Worcester Massachusetts, , United States

Detroit Michigan, , United States

Lansing Michigan, , United States

Duluth Minnesota, , United States

Edina Minnesota, , United States

Columbia Missouri, , United States

Kansas City Missouri, , United States

Hackensack New Jersey, , United States

Morristown New Jersey, , United States

New Brunswick New Jersey, , United States

Summit New Jersey, , United States

Brightwaters New York, , United States

Hawthorne New York, , United States

New York New York, , United States

Pinehurst North Carolina, , United States

Akron Ohio, , United States

Cincinnati Ohio, , United States

Cleveland Ohio, , United States

Columbus Ohio, , United States

Tulsa Oklahoma, , United States

Portland Oregon, , United States

Abington Pennsylvania, , United States

Pittsburgh Pennsylvania, , United States

Providence Rhode Island, , United States

Charleston South Carolina, , United States

Greenville South Carolina, , United States

Nashville Tennessee, , United States

Austin Texas, , United States

Bedford Texas, , United States

Dallas Texas, , United States

Fort Worth Texas, , United States

Houston Texas, , United States

San Antonio Texas, , United States

The Woodlands Texas, , United States

Webster Texas, , United States

Salt Lake City Utah, , United States

Annandale Virginia, , United States

Newport News Virginia, , United States

Roanoke Virginia, , United States

Spokane Washington, , United States

Vancouver Washington, , United States

Green Bay Wisconsin, , United States

Madison Wisconsin, , United States

Milwaukee Wisconsin, , United States

Wauwatosa Wisconsin, , United States

Adelaide , , Australia

Ballarat , , Australia

Brisbane , , Australia

Gosford , , Australia

Parkville , , Australia

Subiaco , , Australia

Toorak Gardens , , Australia

Townsville , , Australia

Wodonga , , Australia

Woodville , , Australia

Guangzhou , , China

Jinan , , China

Shanghai , , China

Shenyang , , China

Beer Sheva , , Israel

Haifa , , Israel

Holon , , Israel

Jerusalem , , Israel

Kfar Saba , , Israel

Petah Tikva , , Israel

Ramat-Gan , , Israel

Rehovot , , Israel

Tel Aviv , , Israel

Zerifin , , Israel

Auckland , , New Zealand

Wellington , , New Zealand

Bydgoszcz , , Poland

Gdańsk , , Poland

Lublin , , Poland

Poznan , , Poland

Warszawa , , Poland

Arkhangelsk , , Russian Federation

Chelyabinsk , , Russian Federation

Ivanovo , , Russian Federation

Kirov , , Russian Federation

Krasnodar , , Russian Federation

Moscow N/a , , Russian Federation

Moscow , , Russian Federation

Nalchik , , Russian Federation

Nizhniy Novgorod , , Russian Federation

Nizhny Novgorod , , Russian Federation

Omsk , , Russian Federation

Orenburg , , Russian Federation

Pyatigorsk , , Russian Federation

Ryazan , , Russian Federation

Saint Petersburg , , Russian Federation

Saint-Petersburg, , , Russian Federation

Sochi , , Russian Federation

St Petersburg , , Russian Federation

Ufa , , Russian Federation

Yaroslavl , , Russian Federation

Amanzimtoti , , South Africa

Cape Town , , South Africa

Durban , , South Africa

Johannesburg , , South Africa

Port Elizabeth , , South Africa

Pretoria , , South Africa

Bern , , Switzerland

Zurich , , Switzerland

Bebington , , United Kingdom

Glasgow , , United Kingdom

Guilford , , United Kingdom

London , , United Kingdom

Maidstone , , United Kingdom

Manchester , , United Kingdom

Plymouth , , United Kingdom

Swansea , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

581

Study ID:

NCT01846611

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider