MDACC Study Summary 2008-0547

Study Summary
No. 2008-0547:.......Sarcoma......Shreyaskumar R. Patel......Sarcoma Medical Oncology

Study Summary Title



Study Summary Number:	2008-0547

Study 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)

Physician

New Patient Referral



Name:	Shreyaskumar R. Patel	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Sarcoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3626 Contact us about clinical trials

General Information



Disease Group:	Sarcoma	Supported By:	PharmaMar S.A.

Phase of Study:	Phase III	Return Visit:	Screening visit, treatment every three weeks in both arms. Labwork on day 1,8 and 15 of each cycle. End of treatment visit.

Treatment Agents:	Doxorubicin Ifosfamide Mesna Trabectedin	Home Care:	Patients can receive supportive care during the trial.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	The goal of this clinical research study is to compare 2 chemotherapy treatments. Trabectedin will be compared with doxorubicin-based therapy (either doxorubicin alone or doxorubicin plus ifosfamide). Researchers want to learn if and how long these treatments may help to control TRS. The safety of these treatments will also be studied.

Study Objectives / Outcomes

Primary

To evaluate the efficacy of trabectedin vs. standard DXCT as first-line treatment of patients with advanced TRS, by comparing PFS in each treatment arm .

Secondary

To compare 6-month PFS rates.

To compare response rates and duration of response, by the Response Evaluation Criteria in Solid Tumors (RECIST).

To compare the exploratory computed tomography (CT) evaluations conducted using the Choi response criteria.

To compare PFS and response rates in the subgroups of patients stratified by histological type Round ( MRCL vs other TRS subtypes).

To compare OS.

To compare the safety profile in each treatment arm.

To perform exploratory, pharmacogenomic (PGx) studies so as to correlate fusion protein type and variants, and DNA repair markers with clinical outcomes.

Study Status Information



Study Activation / Registration Date:	07/22/2009

IRB Review and Approval Date:	12/22/2008

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	100

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient's written informed consent before any study-specific procedures.

2) Adult patients (age greater than or equal to 18 years).

3) Patients with pathological diagnosis of TRS (institutional assessment), of any, but restricted to the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, MRCL and synovial sarcoma. Availability of adequate tumor material for external review is mandatory.

4) Patients must have unresectable locally advanced or metastatic progessive disease prior to enrollment.

5) Measurable disease as defined by the radiological (CT-scan and MRI) Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines.

6) ECOG performance status of 0 to 2.

7) Adequate cardiac function, defined as LVEF within normal limits according to institutional standards, as shown by echocardiography or scintigraphy (MUGA).

8) Hematological variables:a) Hemoglobin greater than or equal to 9 g per dl, b) ANC greater than or equal to 1,500 per microliter, c) Platelet count greater than or equal to 100,000 per microliter.

9) Biochemical variables:a) Serum creatinine less than or equal to 1.5 mg per dl, b) CPK less than or equal to 2.5 x ULN.

10) Hepatic function variables: a)Total bilirubin less than or equal to ULN, unless in case of Gilbert's syndrome b) Total AP less than or equal to 2.5 x ULN, or if greater than 2.5 x ULN consider AP liver fraction, and/or GGT, and /or 5' nucleotidase must be less than or equal to ULN, c) AST/SGOT and ALT/SGPT must be less than or equal to 2.5 x ULN, d) Albumin greater than or equal to 25 g per liter.

Exclusion Criteria:

1) Known hypersensitivity to any of the components of the i.v. formulation of trabectedin or the comparators.

2) Prior chemotherapy treatment.

3) Prior irradiation of the lesion if only one target lesion (ie., measurable) is available.

4) Pregnant or lactating women or men & women of reproductive potential not using effective contraceptive methods (1 or more of the following):a) Complete abstinence from intercourse from 2 wks prior to admin of the study treatment, throughout the study, and for at least 6 mos after completion or premature disc. from the study or b) Physical sterilization of the pt or the pt's partner or c)for female pts or female partners of male pts:implants of levonorgestrel or injectable progestogen or oral contraceptive or any IUD with published data showing failure rate is <1%/yr, or, double barrier method

5) History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more.

6) Brain metastases and/or leptomeningeal metastases, even if treated.

7) Other serious illnesses, such as:a) Congestive heart failure or angina pectoris;myocardial infarction within one year before enrollment;uncontrolled arterial hypertension (according to WHO criteria), arrhythmias or abnormal LVEF.

8) Psychiatric disorder or any other personal circumstances that prevent compliance with the study protocol.

9) Active viral hepatitis or chronic liver disease.

10) Active infection.

11) Any other unstable medical condition.

12) Inability or unwillingness to comply with the study protocol.

13) Prior treatment with any investigational drugs/treatments within 30 days before inclusion into the current study.

Links

Registration Number: NCT00796120
Study Information on Clinical Trials Registry (clinicaltrials.gov)