Solid Tumors

Subjects must have unresectable or metastatic gastric cancer or cancer of the gastroesophageal junction (GEJ) and have not received chemotherapy for advanced disease.

Eligible subjects will be randomized to receive either a modified schedule of DCF (mDCF, Arm A) or the standard regimen parent DCF with growth factor support (Arm B)

Arm A: Docetaxel 30 mg/m2 on day 1, Leucovorin 400 md/m2 on day 1, Fluorouracil 400 mg/m2 on day 1. Fluorouracil 1000 mg/m2 for 48 hours, Cisplatin 40 mg/m2 on day 2 or 3. Arm A subjects will receive study treatment every 2 weeks per each 6 week cycle (3 treatments per cycle).

Arm B: Docetaxel 75 mg/m2 on day 1, Cisplatin 75 mg/m2 on day 1, Fluorouracil 750 mg/m2 daily for 5 days, Neulasta 6 mg on days 8, 9, or 10 or Neupogen 300 or 480 mcg on days 10-17. Arm B will receive study treatment every 3 weeks per each 6 week cycle (2 treatments per cycle).

Tumor assessments for both Arms will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.

Patients must have advanced cancer (solid tumors except breast and prostate cancer) with current or prior radiographic evidence of at least 1 bone metastasis. Patients with current or prior IV or oral bisphosphonate administration for the treatment of bone metastasis/osteolytic lesions are not eligible.

Patients will be randomized to receive one of the following blinded study medications every 4 weeks:

- An injection of Denosumab 120 mg + IV infusion of placebo, or
- An injection of placebo + Zoledronic Acid (Zometa®) 4 mg by IV infusion.

Patients are expected to be on study for 5 to 22 months depending on the extent of disease. Patients will be followed up for 2 years after the end of study treatment.

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)