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Solid Tumors

Ovarian/Peritoneal/Fallopian Tube Cancer

1

Disease Status and/or Stage Advanced
Protocol Title A Phase I/II study of BMS-247550 and Pegylated Liposomal Doxorubicin in Patients with Advanced Ephitelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer Who Have Been Previously Treated with Platinum and Taxane and a Phase I Study of Patients with Metastic Breast Cancer
PI Ellen Chuang, MD
Contact Yulia Dault, RN
212-746-3145
Key Eligibility Must have platinum and taxane resistant disease, (either a disease-free interval of less than 6 months or progression while on the regimen)

No prior treatment with Doxorubicin
Treatment Overview BMS-247550 and Doxil administered day 1 of 21 day cycle

Patients may continue treatment until disease progression or unacceptable side effects.

2

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.

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
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).

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)
  Last updated: July 30, 2008
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