Patient demographics, baseline char acteristics, and prior therap

Patient demographics, baseline char acteristics, and prior therapies are shown in Table 1. Patients had a median age of 54. 5 years and 32 patients had an ECOG perfor mance status of 0. The primary tumor site was ovary in 37 of 39 patients and the most common histology was serous papillary. The median CA 125 level at baseline was 178. 4. Eleven patients had selleckchem Sunitinib known bulky disease defined as having at least 1 tumor 5 cm present and 7 patients had ascites. The best response to prior platinum based ther apy was CR in 61. 5%, PR in 20. 5%, SD in 5. 1%, and pro gressive disease in 12. 8%. These patients had been heavily treated with a median number of 4 prior therapies. Fifteen patients were platinum refractory or primary resistant and 24 patients had secondary plati num resistant disease.

All patients were platinum and paclitaxel refractory or resistant. All patients had received additional non platinum containing salvage agents, including docetaxel in 12, gemcitabine Inhibitors,Modulators,Libraries in 11 and topotecan in 9. All prior platinum containing regimens were counted as 1 regi men. Most patients received 2 or more prior chemotherapy regimens. Twelve patients received 3 or more and 8 patients received 4 or more prior regimens, defining a heavily treated population. Study Treatment Administration Thirty nine patients received a total of 245 cycles of canfosfamide in combination with PLD therapy as shown in Table 2. The median number of cycles per patient was 4. The median cumulative dose of canfosfamide was 3840 mg m2 and of PLD 200. 3 mg m2. Full doses of canfosfamide and PLD were administered in 88.

4% and 87. 3% of cycles, respectively. Dose reduc Inhibitors,Modulators,Libraries tions due to toxicity were infrequent. The most com mon reasons for dose reductions were 14 events Inhibitors,Modulators,Libraries of PPE syndrome and 28 events of neutropenia and or thrombocytopenia. Safety Treatment related AEs related to the combination of canfosfamide and PLD are shown in Table 3. Grade 4 hematologic AEs included neutropenia, leucopenia, and anemia. Febrile neutropenia was observed in 2 patients. Granulocyte growth factor was administered in Inhibitors,Modulators,Libraries 32. 2% of cycles and erythropoietin was administered in 20% of cycles. Red blood cell trans fusions were given in 7. 3% of cycles and a single platelet transfusion was administered in 0. 4% of cycles. Two patients with neutropenic fever received granulocyte col ony stimulating factor for Inhibitors,Modulators,Libraries 3 and 7 days, respec tively, with prompt resolution of neutropenia.

There were no reports of treatment related sepsis or clinical sequelae. The most common non hematological AEs related to the combination of canfosfamide namely and PLD were grade 1 2 and included nausea and vomiting which were well controlled with standard prophylactic antiemetics, rash, and grade 3 fatigue. One patient experienced grade 4 fatigue. There were no signs or symptoms of congestive heart failure and no changes in LVEF as determined by multiple gated acquisition or ECG.

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