Romiplostim in Treating Patients with Chemotherapy-Induced Thrombocytopenia

Inclusion Criteria

• Patients with active non-hematologic cancer: * 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: * Defined as platelet count < 100,000/mcL * The patient will have had at least 2 complete blood counts (CBC) with platelet counts < 100,000/mcL separated by at least 4 weeks, and no platelet count >= 100,000/mcL in the prior 6 week period, despite (1) delay or (2) modification of chemotherapeutic regimen * A platelet count of > 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 (< 100,000/mcL) * Patients have undergone bone marrow aspirate and biopsy, or peripheral blood test in the prior 3 months, without evidence of leukemia or myelodysplasia by fluorescent in situ-hybridization (FISH) * Dysplastic changes, based on morphology only, will not exclude the patient if FISH panel for myelodysplastic syndrome (MDS) is normal
• Karnofsky performance status (KPS) >= 50 or Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Ability to provide written informed consent

Exclusion Criteria

• Patients with history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases; romiplostim has been associated with transient increases in immature blood cell counts and a higher risk for progression to acute myeloid leukemia in myelodysplastic syndrome patients treated with Nplate
• Patients with known bone metastases, with evidence of corticol bone damage/lytric lesions/blastic lesions on standard imaging studies (computed tomography [CT]/magnetic resonance [MR])
• Anemia (hemoglobin [Hgb] < 8.0 gm/dl) or leukopenia (absolute neutrophil count [ANC] < 1,000/mcL); use of red cell transfusions, erythropoietin, or filgrastim (G-CSF), as ordered by the managing oncology service, is acceptable and does not preclude participation
• Patients with underlying liver disease, such as cirrhosis or chronic hepatitis, and do not have primary or metastatic cancer in the liver will be excluded if alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) or total bilirubin (bili) > 3 x ULN; in the presence of primary or metastatic liver cancer, patients will be excluded if ALT/AST > 5 x ULN or total bili > 5 x ULN
• Patients with a history of a prior symptomatic venous thrombotic event, such as deep venous thrombosis (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 intravenous (IV) antibiotics
• Pregnant women/lactating mothers
• Patients unwilling to use contraception