Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

Inclusion Criteria:

1. 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:

1. Nucleoside Analogue, including gemcitabine and fluorouracil

2. Carboplatin or cisplatin

3. Anthracycline

4. Alkylating agent

5. Other chemotherapy agents with thrombocytopenia as known common toxicity.

2. Patients who have not had any cytotoxic chemotherapy within 14 days of beginning the
study.

3. Thrombocytopenia:.

A. Defined as platelet count <100,000/mcL.

B. The patient will have had at least 2 CBCs 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.

C. 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).

D. 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) E. Dysplastic changes, based on morphology only, will not exclude
the patient if FISH panel for MDS is normal.

4.KPS ≥ 50 or ECOG performance status ≤2 .

5.Ability to provide written informed consent.

Exclusion Criteria:

1. Patients with history of hematologic malignancies, including leukemia, myeloma,
myeloproliferative disease, lymphoma, or myelodysplastic diseases.

2. Patients with known bone metastases, with evidence of corticol bone damage/lytic
lesions/blastic lesions on standard imaging studies (CT/MR)

3. Anemia (Hgb <8.0 gm/dl) or leukopenia (absolute neutrophil count (ANC) <1,000/mcL).
Use of red cell transfusions, erythropoietin, or G-CSF, as ordered by the managing
oncology service, is acceptable and does not preclude participation.

4. 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 ALT/AST >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

5. 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.

6. 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

7. Pregnant women/lactating mothers

8. Patients unwilling to use contraception.