Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma

• Register: ClinicalTrials.gov
• Last refreshed on: 10 December 2012
• Main ID: NCT01189253
• Date of registration: 25/08/2010
• Primary sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Public title: Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
• Scientific title: TRUSTS: A Phase IIB/III Multicenter Study Comparing the Efficacy of TRabectedin Administered as a 3-Hour or 24-Hour Infusion to Doxorubicin in Patients With Advanced or Metastatic Untreated Soft Tissue Sarcoma
• Date of first enrolment: May 2011
• Target sample size: 370
• Recruitment status: Suspended
• URL: http://clinicaltrials.gov/show/NCT01189253
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment

Countries of recruitment

Austria, Belgium, Denmark, France, Germany, Hungary, Netherlands, Poland, Slovakia, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: James E. Butrynski, MD
• Affiliation: Dana-Farber Cancer Institute

• Name: Nguyen Binh Bui, MD
• Affiliation: Institut Bergonié

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed intermediate- or high-grade malignant soft tissue sarcoma

- Advanced and/or metastatic disease

- Previously untreated disease

- The following tumor types are not allowed:

- Well-differentiated liposarcoma

- Embryonal rhabdomyosarcoma

- Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)

- Osteosarcoma (excluding extraskeletal osteosarcoma)

- Ewing tumors/primitive neuroectodermal tumor (PNET)

- Gastrointestinal stromal tumors (GIST)

- Dermatofibrosarcoma protuberans

- Must have confirmed disease progression based on investigator's judgment prior to
study enrollment

- Measurable disease according to RECIST v 1.1 criteria

- Tumor lesions situated in a previously irradiated area, or in an area subjected
to other loco-regional therapy, are usually not considered measurable unless
there has been demonstrated progression in the lesion

- Formalin fixed paraffin embedded tumor blocks or representative hematoxylin/eosin
slides (preferably both) available (local histopathological diagnosis will be
accepted for trial entry)

- No prior anticancer therapy for this disease

- No prior anthracycline

- Non-anthracycline therapy for nonmetastatic disease is acceptable

- No known history of CNS metastases or leptomeningeal tumor spread

PATIENT CHARACTERISTICS:

- WHO performance status 0-1

- Absolute neutrophil count = 1.5 x 10^9/L

- Hemoglobin = 9 g/dL

- Platelet count = 100 x 10^9/L

- Bilirubin normal

- ALT/AST = 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase = 2.5 times ULN, (if alkaline phosphatase > 2.5 times ULN,
hepatic isoenzymes 5-nucleotidase and/or GGT must be within the normal range)

- Albumin > 30 g/L

- Serum creatinine = 1.5 times ULN

- Creatinine clearance = 30 mL/min

- Creatine phosphokinase (CPK) = 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception (double barrier method for men) 2
weeks prior to, during, and for 3 months (women) or 5 months (men) after completion
of study therapy

- LVEF normal by MUGA scan or ECHO

- 12-lead ECG normal (without clinically significant abnormalities)

- None of the following unstable cardiac conditions:

- Congestive heart failure

- Angina pectoris

- Myocardial infarction within the past year

- Uncontrolled arterial hypertension, defined as BP = 150/100 mm Hg despite
optimal medical therapy

- Clinically significant arrhythmias

- No active or uncontrolled infections or serious illnesses or medical conditions,
including a history of any of the following:

- Chronic alcohol abuse

- Hepatitis

- HIV

- Cirrhosis

- No history of malignancy within the past 5 years, except soft tissue sarcoma, basal
cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix,
resected incidental prostate cancer (staged pT2 with Gleason score = 6 and
postoperative PSA < 0.5 ng/mL)

- Patients with any history of malignancies who are disease-free for more than 5
years are eligible

- a history of malignancy and disease-free for more than 5 years

- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule

- No concurrent alcohol consumption

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 28 days since prior and no concurrent anticancer therapy including systemic
therapy, radiotherapy, or surgery

- At least 28 days since prior and no other concurrent investigational agents

- No concurrent phenytoin, live attenuated vaccines, or yellow fever vaccine



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Sarcoma

Intervention(s)

Drug: doxorubicin hydrochloride

Drug: trabectedin

Other: laboratory biomarker analysis

Procedure: quality-of-life assessment

Primary Outcome(s)

Progression-free survival as assessed by RECIST v 1.1 criteria (phase IIB and phase III) [Time Frame: No]

Safety (phase IIB) [Time Frame: Yes]

Secondary Outcome(s)

Overall survival (phase III) [Time Frame: No]

Quality of life (phase III) [Time Frame: No]

Response rate and response duration (phase III) [Time Frame: No]

Safety profile (phase III) [Time Frame: Yes]

Secondary ID(s)

2009-014889-26

EORTC-62091

EU-21059

PMAR-EORTC-62091

SARC-020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sarcoma Alliance for Research through Collaboration