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| Disease Status and/or Stage | Stage II or III Rectal Cancer |
|---|---|
| Protocol Title | E5204: Intergroup Randomized Phase III Study of Prospective Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Flourouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation |
| PI | Allyson Ocean, MD |
| Contact | Kristen Petrillo, RN 212-746-5430 |
| Key Eligibility | Patients must have histologically-proven adenocarcinoma of the rectum with no distant metastases. Patients must have received a minimum radiation dose of 40Gy and not more than 54 Gy. If patients did not participate in NSABP R-04, they must have received one of the treatments listed: |
| Treatment Overview | Patients are randomized to receive oxaliplatin/leucovorin/5-FU or oxaliplatin/leucovorin/5-FU/bevacizumab |
| Disease Status and/or Stage | Any Stage of Cancer |
|---|---|
| Protocol Title | Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism (VTE) in Patients with Cancer |
| PI | Scott Tagawa, MD |
| Contact | Kristen Petrillo, RN 212-746-5430 |
| Key Eligibility | 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. |
| Treatment Overview | 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). |