Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

Inclusion Criteria

• Patients (18 years of age or greater) with active non-hematological cancer:

A. The patients have previously received a chemotherapy regimen including one or more of the following agents:

• Nucleoside Analogue, including gemcitabine and fluorouracil
• Carboplatin or cisplatin
• Anthracycline
• Alkylating agent
• Other chemotherapy agents with thrombocytopenia as known common toxicity.
• Patients who have not had any cytotoxic chemotherapy within 14 days of beginning the study.
• Thrombocytopenia:.

A. Defined as platelet count 100,000/mcL, that follows within 7 days of a platelet transfusion, will not make the patient ineligible, as long as one or more subsequent platelet counts confirms thrombocytopenia ( 3X ULN or Total Bili >3X ULN. In the presence of primary or metastatic liver cancer, patients will be excluded if ALT/AST >5X ULN or Total Bili >5X ULN

• Patients with a history of a prior symptomatic venous thrombotic event such, as DVT or pulmonary embolism and symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebral vascular accident or transient ischemic attack will be ineligible if they have not tolerated anticoagulation therapy. If patients remain on anticoagulation, or have completed the prescribed course of anticoagulation, they will be eligible for enrollment. A venous thrombotic event associated with a central venous catheter will not make the patient ineligible.
• Serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics
• Pregnant women/lactating mothers
• Patients unwilling to use contraception.