A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma



Status:Active, not recruiting
Healthy:No
Age Range:15 - Any
Updated:4/21/2016
Start Date:June 2011
End Date:April 2016

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A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

The purpose of this study is to evaluate whether overall survival for the trabectedin group
is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or
leiomyosarcoma).

This is a randomized study (study drug assigned by chance) using a 2:1 randomization. It is
an open-label (all people know study drug), active-controlled (comparing to a different drug
used for the same condition), parallel-group (different treatment groups continue with
separate treatments throughout the study), multicenter study. This study will be divided
into 3 phases, screening, treatment, follow-up and optional extension phase (OEP). During
screening, potential participants will be assessed for study eligibility after providing
signed informed consent. Approximately 570 patients who satisfy all inclusion and exclusion
criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n=380) or
dacarbazine (n=190) treatment groups. During the treatment phase, patients will receive
study drug once every 3 weeks, until disease progression (defined by Response Evaluation
Criteria in Solid Tumors [RECIST] Version 1.1 criteria) or signs of toxicity. Assessments
will be performed to evaluate the effectiveness of the drug, and patient safety will be
monitored. During the follow-up phase, after the last dose of study drug, clinical outcomes
for patients will be evaluated. Trabectedin will be administered at a dose of 1.5 milligram
per square meters (mg/m^2) through a catheter into a large vein as a 24-hour intravenous
(IV) infusion, once every 3 weeks, until disease progression or signs of toxicity.
Dacarbazine will be administered at a dose of 1.0 g/m^2 as a 20-120 minute infusion, once
every 3 weeks, until disease progression or signs of toxicity. In the OEP, participants who
were previously randomized to the dacarbazine group will have the option to receive
trabectedin at the discretion of the investigator.

Inclusion Criteria:

- Histologically proven, unresectable, locally advanced or metastatic liposarcoma
(dedifferentiated, myxoid round cell, or pleomorphic) or leiomyosarcoma. Participants
must have a pathology report indicating the diagnosis of liposarcoma or
leiomyosarcoma that has been reviewed by the sponsor before randomization may occur

- Treated in any order with at least: an anthracycline and ifosfamide containing
regimen, or an anthracycline containing regimen and 1 additional cytotoxic
chemotherapy regimen

- Measurable disease at baseline in accordance with RECIST Version 1.1

- Pathology specimens (example [e.g.], tumor blocks or unstained slides) for potential
centralized pathology review and biomarker studies

- ECOG Performance Status score of 0 or 1

- Adequate recovery from prior therapy, all side effects (except alopecia) have
resolved to Grade 1 or less according to the National Cancer Institute - Common
Terminology Criteria of Adverse Events (NCI-CTCAE) Version 4.0

- Adequate organ function as evidenced by the following peripheral blood counts or
serum chemistry values: hemoglobin 9 gram per deciliters (g/dL), absolute neutrophil
count (ANC) 1,500/L, platelet count 100,000/L, serum creatinine 1.5*the upper limit
of normal (ULN), creatine phosphokinase (CPK) 2.5 Upper Limit of Normal [ULN]

- Adequate hepatic function as evidenced by the following serum chemistry values: total
bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure indirect
bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal
range, participant may be eligible) ALP 2.5 x ULN; Trabectedin: if the ALP is >2.5 x
ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST and
ALT 2.5 ULN

- Negative pregnancy test (urinary or serum beta-HCG) at screening (applicable to women
of child bearing potential who are sexually active)

- Female participants must be postmenopausal (no spontaneous menses for at least 2
years), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal
ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of
the investigator), or if sexually active, be practicing an effective method of birth
control. Male participants must agree to use an adequate contraception method as
deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner
using effective contraception) and to not donate sperm for a minimum of 5 months
after treatment discontinuation

Optional Extension Phase (OEP) Phase:

- Documentation for inclusion criteria histologically proven, unresectable, locally
advanced or metastatic liposarcoma (dedifferentiated, myxoid round cell, or
pleomorphic) or leiomyosarcoma. Participants must have a pathology report indicating
the diagnosis of liposarcoma or leiomyosarcoma that has been reviewed by the sponsor
before randomization may occur and treated in any order with at least: an
anthracycline and ifosfamide containing regimen, or an anthracycline containing
regimen and 1 additional cytotoxic chemotherapy regimen do not need to be reviewed by
the Sponsor

- Collection of the specimen: Pathology specimens (example (e.g.), tumor blocks or
unstained slides) for potential centralized pathology review and biomarker studies is
not applicable

- Documentation of inclusion criteria adequate organ function as evidenced by the
following peripheral blood counts or serum chemistry values: hemoglobin 9 gram per
deciliters (g/dL), absolute neutrophil count (ANC) 1,500/L, platelet count 100,000/L,
serum creatinine 1.5*the upper limit of normal (ULN), creatine phosphokinase (CPK)
2.5*ULN and adequate hepatic function as evidenced by the following serum chemistry
values: total bilirubin, ULN. If total bilirubin is greater than (>) ULN, measure
indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within
normal range, participant may be eligible) ALP <= 2.5*ULN; Trabectedin: if the ALP is
>2.5*ULN, then an ALP liver fraction or 5-nucleotidase must be obtained and ULN, AST
and ALT 2.5 ULN will be reviewed by the Sponsor before enrollment in the OEP may
occur

Exclusion Criteria:

- Potential participants who meet any of the following criteria will be excluded from
participating in the study: Prior exposure to trabectedin or dacarabazine, less than
3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy
with any investigational agent, other malignancy within past 3 years. Exceptions:
basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in
situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1
carcinoma of the cervix

- Known 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)

- Myocardial infarct within 6 months before enrollment, New York Heart Association
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

- Uncontrolled intercurrent illness including, but not limited to, poorly controlled
hypertension or diabetes, ongoing active infection, or psychiatric illness/social
situation that may potentially impair the participant's compliance with study
procedures

- Unwilling or unable to have a central venous catheter

- Known allergies, hypersensitivity, or intolerance to trabectedin, dacarbazine,
dexamethasone, or their excipients

- Pregnant or breast-feeding

- 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

OEP phase:

- Potential participants who meet any of the following criteria will be excluded from
Participating in the study: Prior exposure to trabectedin, less than 3 weeks from
last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any
investigational agent, other malignancy within past 3 years. Exceptions: basal or
nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or
Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of
the cervix does not apply

- Treated in any order with at least: an anthracycline and ifosfamide containing
regimen, or an anthracycline containing regimen and 1 additional cytotoxic
chemotherapy regimen with less than 3 weeks from last dose of systemic anticancer
therapy, radiation therapy, or therapy with any investigational agent

- Known allergies, hypersensitivity, or intolerance to dacarbazine does not apply
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