Solid Tumors

Subjects must have histologically/cytologically confirmed urothelial carcinoma that is either metastatic or locally recurrent after local therapy and is not curable by surgery or radiation.

Patients must have received 4-6 cycles of standard chemotherapy and achieved stable disease, partial response, or complete response to chemotherapy.

Patients must be registered within 28 days of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose.

Subjects will receive single agent blinded Sutent or placebo at 50 mg/day orally for 4 consecutive weeks followed by a 2-week rest period beginning on Day 1 of the study. The study drug dose may be adjusted according to individual tolerance. Patients will have a physical exam and laboratory evaluations monthly. During study treatment with study drug, tumor assessment will be done every 12 weeks using a CT or MRI scan and bone scan, if applicable irrespective of dose delays.

Patients may remain on study until disease progression or unacceptable toxicity. Patients demonstrating evidence of objective progression by imaging at the first tumor assessment at 12 weeks will be unblinded. Patients who are on placebo will be crossed over to Sutent and those progressing on Sutent will be removed from study.

Eligible subjects must have previously untreated, confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic (lymph node or visceral) urothelial tract or bladder cancer

Eligible subjects will be randomized to one of the following open-label regimens: (1) Larotaxel 50 mg/m2 infusion on day 1 every 3 weeks plus cisplatin 75 mg/m2 infusion on day 1 every 3 weeks; or (2) gemcitabine 1000 mg/m2 infusion on days 1, 8, and 15 every 4 weeks plus cisplatin 70 mg/m2 infusion on day 1 every 4 weeks. Subjects will also be pre-medicated according to the protocol to prevent potential side effects. Subjects will receive tumor assessments at baseline and every 8 weeks during the study, and as clinically indicated, and be followed up every 3 months after discontinuing study drug. Laboratory tests will also be performed at study visits throughout the course of the study for safety purposes. Complete blood counts will be performed every week while the patietn is on study drug and blood chemistries will be performed once per study treatement cycle (3 or 4 weeks). Subjects may receive study treatment until tumor progression, unacceptable toxicity, or withdrawal of consent.

VTE Treatment Group: Eligible subjects must be age 18 years or older, diagnosed with active cancer and have a documented first venous thromboembolic event. Subjects must be currently receiving any treatment for cancer. In addition, subjects must have a documented first venous thromboembolic event (VTE). Subjects must not be in need of long-term anticoagulant therapy or be undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia or has other conditions associated with persistent thrombocytopenia of less than 100x109/L for a duration of at least four consecutive weeks.

Control Group Patients: Eligible control patients will be matched patients aged 18 years or older and diagnosed with active cancer meeting the same criteria as above but without thrombosis

All eligible subjects with VTE will receive tinzaparin 175 U/kg/day for at least 6 months with another 6 months at the investigator's discretion (up to one year study treatment). Plasma markers of hemostasis, fibrolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months after start of tinzaparin treatment (if subject agrees).

Patients with cancer but without blood clots (control group) will also be enrolled in this study but will not receive study drug. For these patients, information regarding overall heath and response to their cancer treatment will be monitored. Plasma markers of hemostasis, fibrinolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months (if subject agrees)