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Current Lines of Research Clinical and Translational Studies Javier Martín Broto MD PhD ViceChairman of GEIS Medical Oncologist [email protected]

Recently Closed Clinical Trial PHASE II RANDOMIZED STUDY OF SEQUENTIAL DOSE-DENSE DOXORUBICIN AND IFOSFAMIDE VERSUS S-D DOXORUBICIN IN FIRST-LINE ADVANCED STS 132 pts from 23 centers from Spain and Portugal Treatment Schedule: ARM A: Doxorubicin 75 mg/m2 ARM B: Doxorubicin 90 mg/m2 + Ifosfamide 12.5 g/m2 Study Design: Randomized phase II study. Endpoint: PFS. Premature RR differences observed closure if less than 25%

(J Clin Oncol. 2009 Apr 10;27(11):1893-8.)

Recently Closed Clinical Trial PHASE II RANDOMIZED STUDY OF SEQUENTIAL DOSE-DENSE DOXORUBICIN AND IFOSFAMIDE VERSUS S-D DOXORUBICIN IN FIRST-LINE ADVANCED STS

Recently Closed Clinical Trial PHASE II RANDOMIZED STUDY OF DTIC AND GEMCITABINE VS. DTIC ALONE IN PRETREATED STS 113 pts from 18 centers Treatment Schedule: ARM A: DTIC 1200 mg/m2 ARM B: Gemcitabine 1800 mg/m2/min + DTIC 1200 mg/m2 Study Design: Randomized phase II study. Endpoint: PFR at 3 months (ASCO 2009 )

Recently Closed Clinical Trial PHASE II RANDOMIZED STUDY OF DTIC AND GEMCITABINE VS. DTIC ALONE IN PRETREATED STS

Arm A: DTIC Arm B: Gemcitabine + DTIC

p = 0.005 PFS

PHASE II STUDY OF NEOADJUVANT HIGH-DOSE IFOSFAMIDE AND RADIOTHERAPY IN HIGH-RISK LOCALIZED STS

· SELECTION CRITERIA: Localized high-risk STS (>5cm,G 2-3) · TREATMENT SCHEDULE: - Neoadjuvant Ifosfamide, 12 gr/m2 in 5 days x 3 cyc. - Concomitant preop. Radiotherapy, 50 Gy - Surgery, 4 weeks after last chemo cycle · STUDY DESIGN: - Multicenter phase II study. Two stage design: 32 pts - Substudies: · Impact of neoadjuvant treatment in surgery

· Correlation of radiological and pathological response

- Translational study: Identification of predictive markers of response (SNP, cDNA arrays)

PHASE I/II STUDY OF FIRST-LINE NON-PEGYLATED LIPOSOMAL DOXORUBICIN IN PATIENTS OLDER THAN 65 YEARS WITH ADVANCED STS · Studies of chemotherapy in elderly patients with STS are scarce Liposomal doxorubicin might have tolerance advantages · SELECTION CRITERIA: Patients older than 65 years, with advanced non-previously treated STS

· STUDY DESIGN: - Phase I: Dose escalation design - Phase II: Multicenter phase II study. 35 pts · Assessment of Cardiotoxicity

PHASE I/II STUDY OF IFOSFAMIDE IN COMBINATION WITH SORAFENIB IN ADVANCED STS

· Studies in preclinical models suggested an additive antitumor effect between VEGFR inhibitors and Chemo · SELECTION CRITERIA: - Phase I: Advanced Bone and STS - Phase II: STS pretreated with Doxo. No prior Ifos. · STUDY DESIGN: - Phase I: Dose scalation design - Phase II: Multicenter phase II study. 35 pts · TRANSLATIONAL STUDY: Expression of tumor and serum angiogenic factors

RANDOMIZED PHASE II STUDY OF TRABECTEDIN AND DOXORUBICIN VS. DOXORUBICIN ALONE IN ADVANCED STS - Selection Criteria: Advanced untreated STS

- Treatment Schedule:

ARM A: Trabectedin 1.1 mg/m2 (3h) + Doxorubicin 60 mg/m2 ARM B: Doxo 75 mg/m2

- Study design: Multicenter phase II study. 185 pts - Translational Study: DNA reparation pathways

PHASE II TRIAL ON LOCALIZED EWING SARCOMA - Selection Criteria: Standard and High Risk patients

- Treatment Schedule:

Standard risk: 2 CPM-DOX-VNC + 1 VP16-IFOS High Risk: 2 GEM-DOC Mp6 Surg 1CPM-DOX-VNC + 1VP16-IFOS RTP

GEM-DOC (if at least Response in Window phase)

- Main End Point: DFS at 3 y

Colaboration

· · · · · ISG 3 vs 5 cycles stage III STS EORTC Intergroup 62024 MSKCC Nomogram for GIST EORTC Intergroup 62063 ...

· Close collaboration between clinicians and basic researchers is necessary to design studies that will provide anwers to outstanding questions

· Intergroup collaboration of national groups should be encouraged to investigate several of the important questions concerning rare sarcomas

[email protected]

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