Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Ifosfamide

Sorafenib

Isophosphamide mustard

Mesna

Protein Kinase Inhibitors

Enzyme Inhibitors

Phase I:

Level 1: Sorafenib 200 mg bid, orally Ifosfamide 2,0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration

Level 2: Sorafenib 400 mg bid, orally Ifosfamide 2.00 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration

Level 3 : Sorafenib 400mg bid, orally Ifosfamide 2.5 g/m2 , intravenously , over 4 hours , on 3 consecutive days . Mesna 500mg/m2,iv,at 0,4 and 8 hours after ifosfamide administration .

Level 4 : Sorafenib 400 mg bid, orally Ifosfamide 3.0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 600 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration

Phase II:

Sorafenib and Ifosfamide administered at the doses recommended in phase I until progression or unacceptable toxicity.

Xavier Garcia del Muro, MD

Soft tissue sarcomas (STS) are an uncommon group of malignant tumors of mesenchymal origin. For most advanced STS types, chemotherapy is currently the only available treatment. Unfortunately, a very limited number of useful drugs are active against this disease. Doxorubicin is widely considered the standard first-line treatment. Ifosfamide has also a well-established activity (1,2) and is often administered either associated with Doxorubicin or alone as a second-line chemotherapy treatment. Other drugs such as DTIC, Gemcitabine and Temozolomide showed modest activity as a second-line agents (3,4). Thus, there is a necessity to identify new agents with activity to improve therapy for patients with advanced STS. In some studies, most STS showed VEGF expression, and elevated serum VEGF levels were found to correlate with higher histologic tumor grade (5,6). Additionally, inhibition of VEGFR was associated with tumor activity in preclinical models of sarcoma (7,8). For these reasons, inhibition of VEGFR seems to be a reasonable approach to explore in the treatment of STS. Sorafenib (BAY 43-9006) is an orally available, small molecule multi-kinase inhibitor of VEGFR, PDGFR and RAF with demonstrated activity in the treatment of renal cell cancer (9). Preclinical studies suggest that the combination of Sorafenib with cytotoxic agents results in additive anti-tumor activity (10), initiating justification for combination studies. A recent trial, however, reported an unexpected incidence of cardiac toxicity in patients with STS treated with Bevacizumab, a monoclonal antibody that binds VEGF, in combination with Doxorubicin (11). This finding suggest that the possibility of potentiation of the cardiotoxicity of Doxorubicin when inhibiting the VEGF pathway cannot be ruled out. The association of Sorafenib with Ifosfamide, the other established active agent against STS, could improve the efficacy of single-agent Ifosfamide minimizing the risk of cardiac toxicity .

Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma

Phase I-II, Not-Randomized, Multicenter Clinical Trial to Evaluate Safety and Efficacy of Sorafenib (BAY-43-9006) in Combination With Ifosfamide in Soft Tissue Sarcoma.

Grupo Espanol de Investigacion en Sarcomas

Grupo Espanol de Investigacion en Sarcoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma	NCT00541840	Soft Tissue Sar...	Sorafenib	18 Years - 72 Years	Grupo Espanol de Investigacion en Sarcomas
Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma	NCT00541840	Soft Tissue Sar...	Sorafenib	18 Years - 72 Years	Grupo Espanol de Investigacion en Sarcomas

Spots Global Cancer Trial Database for geis

Every month we try and update this database with for geis cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for geis

Every month we try and update this database with for geis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for geis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.