A Study of LY573636-Sodium in the Treatment of Patients With Metastatic Soft Tissue Sarcoma

• Objective response rate (complete response + partial response). [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]
• Clinical benefit rate (complete response + partial response + stable disease). [ Time Frame: Baseline to measured progressive disease. ] [ Designated as safety issue: No ]
• Pharmacokinetics. [ Time Frame: Before and after each dose (Cycles 1 through 6). ] [ Designated as safety issue: No ]
• Overall survival time. [ Time Frame: Baseline to date of death from any cause. ] [ Designated as safety issue: Yes ]
• Duration of overall objective response. [ Time Frame: From time of response to time of measured progressive disease. ] [ Designated as safety issue: No ]
• Duration of stable disease. [ Time Frame: Time from stable disease to time of measured progressive disease. ] [ Designated as safety issue: No ]
• Safety [ Time Frame: Every cycle. ] [ Designated as safety issue: Yes ]

• Objective response rate (complete response + partial response). [ Time Frame: Patients will be assessed for clinical progression at every visit and for response by CT-scans every other visit (~every 42 days). ]
• Clinical benefit rate (complete response + partial response + stable disease). [ Time Frame: Patients will be assessed for clinical progression at every visit and for response by CT-scans every other visit (~every 42 days). ]
• Pharmacokinetics. [ Time Frame: Samples will be collected before and after each dose (up to 6 cycles of treatment). Data will be reviewed every 3 months to determine if changes to the dosing regimen are needed to ensure patient safety. ]
• Overall survival time. [ Time Frame: A post-treatment follow-up evaluation will be completed approximately 30 days following the last dose of study drug received. Patient disposition will then be assessed approximately every 2 months (60 days) until death or until the end of the study. ]
• Duration of overall objective response and stable disease. [ Time Frame: Patients will be assessed for clinical progression at every visit and for response by CT-scans every other visit (~every 42 days). ]
• Safety. [ Time Frame: Safety data will be monitored closely and reviewed every 3 months to determine if changes to the dosing regimen are needed to ensure patient safety. ]

The primary purpose of the study is to estimate the time from the first dose of LY573636 to the date your physician determines that your disease has progressed or worsened.

Patients will receive a 2-hour intravenous infusion of study drug (LY573636) once every 21 days or 28 days depending on their target dose. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 42 days or 56 days (every other cycle).

Inclusion Criteria:

• Diagnosis of soft tissue sarcoma that is unresectable or metastatic
• Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin).
• Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days

Exclusion Criteria:

• Patients with primary bone sarcoma (e.g. osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma
• Serious pre-existing medical problems (as determined by your doctor)
• Have received more that two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma
• Have a second primary cancer (unless cancer-free for more than 2 years)
• Active treatment with Warfarin (Coumadin)