Clinical trial NCT00718484 (phase 2, status: unknown status)
Conditions: soft tissue sarcoma
ICD codes: C46.1
Drugs: palifosfamide tris and doxorubicin, doxorubicin
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥18 years

          2. Histological or cytological documentation of sarcoma (excluding alveolar soft-part
             sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma,
             mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low
             grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1
             prior regimen for metastatic/unresectable disease, and for whom treatment with
             doxorubicin is considered medically acceptable. Prior treatment with IFOS is
             acceptable.

          3. Have measurable disease as per RECIST criteria (Appendix 2)

          4. ECOG Performance Status of 0 or 1 (Appendix 3)

          5. Anthracyclin naïve

          6. Life expectancy of ≥12 weeks

          7. Adequate bone marrow, liver, and renal function, as assessed by the following
             laboratory requirements conducted within 14 days prior to dosing:

               1. Hemoglobin ≥9.0 g/dL

               2. Absolute neutrophil count (ANC) ≥1,500/mm3

               3. Platelet count 100,000/mm3

               4. Total bilirubin ≤1.5×ULN (upper limit of normal)

               5. ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease

               6. Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT]
                  <1.5×ULN (≤2.0×ULN for subjects on anticoagulation prophylactic regimen).
                  Subjects who are being therapeutically anticoagulated with an agent such as
                  Coumadin (warfarin sodium) or heparin are allowed provided there is no prior
                  evidence of underlying abnormality in coagulation parameters. If an interaction
                  between study drug and anticoagulant is suspected, anticoagulation monitoring
                  should be increased as appropriate.

               7. Serum creatinine ≤ULN

          8. Written informed consent must be obtained from a potential subject prior to the
             conduct of any study-specific procedures

          9. Male and female subjects must agree to use adequate birth control measures/barrier
             control during the course of the trial

         10. Women of childbearing potential must have a urine pregnancy test performed within 14
             days of the start of treatment

        Exclusion Criteria:

          1. Has any one of the following sarcoma sub types: alveolar soft-part sarcoma,
             chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed
             mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade
             liposarcoma.

          2. Clinically evident congestive heart failure >Class II of the New York Heart
             Association (NYHA) guidelines (Appendix 4)

          3. Serious, clinically significant cardiac arrhythmias, defined as the existence of an
             absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V
             (Appendix 4)

          4. History and/or signs of active coronary artery disease/ischemia with or without angina
             pectoris

          5. Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated
             acquisition scan], myocardial scintigram) or ultrasound-determined absolute left
             ventricular ejection fraction (LVEF) <45%

          6. History of HIV infection

          7. Prior nephrectomy or history of urinary tract obstruction

          8. Active, clinically serious infection requiring systemic antibacterial, antifungal, or
             antiviral therapy

          9. Any major surgery within 3 weeks prior to start of treatment

         10. Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive
             therapy and has a negative imaging study within 4 weeks of study entry. In addition,
             the subject must not be undergoing acute steroid therapy or taper (chronic steroid
             therapy is acceptable, provided the dose is stable for 1 month prior to study start,
             and following screening radiographic studies).

         11. Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell
             carcinoma, or superficial bladder tumors [Ta, Tis, & T1] or other malignancies
             curatively treated >5 years prior to entry)

         12. Pregnancy or lactation

         13. Substance abuse or medical, psychological, or social conditions that may interfere
             with the subject's participation in the study or evaluation of the study results

         14. Any condition that is unstable or could jeopardize the safety of a subject and his/her
             compliance with the protocol requirements

             In addition, use of the following therapies and medications-prior or concomitant-would
             exclude a subject from this study:

         15. Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during the
             study or within 4 weeks of study entry (6 weeks for Mitomycin C)

         16. Prior treatment with doxorubicin

         17. Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is
             permitted if started or planned prior to Cycle 1, Day 1)

         18. Bone marrow transplant or stem cell rescue within 4 months of study entry

         19. Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or
             biological response modifiers within 3 weeks of study entry