Phase III Trial of Trabectedin vs DXCT first line in patients with TRS

• Research type

  Research Study

• Full title

  A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis®) versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients with Translocation-Related Sarcomas (TRS)

• IRAS ID

  11499

• Sponsor organisation

  PharmaMar SA, Sociedad Unipersonal

• Eudract number

  2008-002326-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study design will be a multicenter, randomized, phase III study of single-agent trabectedin vs.doxorubicin-based chemotherapy administered as first-line therapy to patients with unresectable locally advanced or metastatic, pathologically confirmed TRS(translocation-related sarcoma).Patients fulfilling all eligibility criteria will be stratified according to the Eastern Cooperative Oncology Group(ECOG)Performance Status(PS)score(0 vs.1-2)and pathological subtype of sarcoma (myxoid-round cell liposarcoma vs.other TRS suptypes)and then randomized at a 1:1 ratio to receive trabectedin or doxorubicin based chemotherapy. Treatment Arm A:Trabectedin 1.5 mg/m2 given as a 24 h c.i.v.i. (continuous intravenous infusion). Trabectedin treatment will be continued in the absence of disease progression or intolerable side effects.Treatment Arm B:Doxorubicin as a single agent 75 mg/m2 i.v. every three weeks; or doxorubicin 60 mg/m2 i.v. followed by ifosfamide range 6 to 9 g/m2 i.v. every three weeks with proper hydration and mesna administration. Patients in this Arm will continue receiving doxorubicin therapy in the absence of disease progression or intolerable side effects, until the maximum cumulative dose according to institutional standards has been reached or if the left ventricular ejection fraction (LVEF) is compromised due to reduction of cardiac function below the institutional standard. Once doxorubicin has been discontinued, patients may also discontinue the second drug in the combination regime according to Investigator's discretion.Upon disease progression, subsequent therapies for patients in either treatment arm may be provided off-study according to the Investigators' criteria.

• REC name

  Scotland A REC

• REC reference

  08/MRE00/110

• Date of REC Opinion

  23 Feb 2009

• REC opinion

  Further Information Favourable Opinion