Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma

NCT00579501 | Completed Phase 2 Results DMC

• 2 other identifiers: CR014767ET-B-028-06
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).

Conditions

Liposarcoma,Myxoid

Keywords

Myxoid; Liposarcoma; Trabectedin; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pathological Complete Response (pCR)

  Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.

  Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.

Secondary Outcomes (1)

• Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)

  Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.

Study Arms (1)

Trabectedin

EXPERIMENTAL

Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion.

Drug: Trabectedin; Drug: Dexamethasone

Interventions

Trabectedin DRUG

Trabectedin 1.5 mg/m\^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin.

Trabectedin

Dexamethasone DRUG

Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion

Trabectedin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
• Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery
• Measurable disease (by Response Evaluation Criteria In Solid Tumors \[RECIST\])
• No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

You may not qualify if:

• Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone
• Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods
• History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
• Known distant metastases
• Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PharmaMar: collaborator

Study Sites (8)

Unknown Facility

Coeur d'Alene, Idaho, United States

Location

Unknown Facility

Park Ridge, Illinois, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Bourdeaux, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Mannheim, Germany

Location

Related Publications (1)

• Gronchi A, Bui BN, Bonvalot S, Pilotti S, Ferrari S, Hohenberger P, Hohl RJ, Demetri GD, Le Cesne A, Lardelli P, Perez I, Nieto A, Tercero JC, Alfaro V, Tamborini E, Blay JY. Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Ann Oncol. 2012 Mar;23(3):771-776. doi: 10.1093/annonc/mdr265. Epub 2011 Jun 3.

  PMID: 21642514 DERIVED

MeSH Terms

Conditions

Liposarcoma, Myxoid; Liposarcoma

Interventions

Trabectedin; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Medical Specialist, Clinical Oncology
• Organization: PharmaMar SA, Av de los Reyes 1 Mine Industrial Estate, 28770 Colmenar Viejo, Madrid, Spain

+34 91 646-6087

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 7, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-04

Locations

FR (3); US (4); DE (1)