Clinical trial NCT00060944: A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
Official title: A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liposarcoma
Leiomyosarcoma
Keywords: Trabectedin
Yondelis
ET-743
Ecteinascidin
Anthracycline
Ifosfamide
Dexamethasone
Intravenous
Cancer
Malignant
Metastatic
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PharmaMar
First posted: 2003-05-19
Enrollment: 271
Sex: ALL
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 this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

Detailed description: This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.

Eligibility criteria: Inclusion Criteria:

* Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
* Have a pathology specimen available for centralized review
* Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
* Have adequate bone marrow, liver and kidney function
* Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
* Cancer that has metastasized (spread) to the central nervous system
* Active viral hepatitis or chronic liver disease
* Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
* History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment

Primary outcomes:
measure: Time to Progression- Independent Review
timeFrame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Secondary outcomes:
measure: Percentage of Participants Objective Response - Independent Review
timeFrame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
measure: Duration of Response - Independent Review
timeFrame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
measure: Progression-Free Survival - Independent Review
timeFrame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
measure: Overall Survival
timeFrame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Coeur D Alene
country: United States
state: Idaho
city: Park Ridge
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: East Melbourne
country: Australia
city: Newcastle
country: Australia
city: Perth
country: Australia
city: Woodville
country: Australia
city: Leuven
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Edmonton
country: Canada
city: Lyon
country: France
city: Villejuif
country: France
city: Düsseldorf
country: Germany
city: Moscow N/A
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk N/A
country: Russian Federation
city: Samara N/A
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Barcelona
country: Spain
city: Valencia N/A
country: Spain
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: