Study of Romiplostim Versus Observation for Chemotherapy Induced Thrombocytopenia
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Isolated Chemotherapy-induced Thrombocytopenia
Intervention: romiplostim, (Biological); Control cohort (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Gerald Soff, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center
Overall contact: Gerald Soff, MD, Phone: 212-639-2335
Summary
This study is to determine if using weekly romiplostim injections will improve the patient's
platelet count more effectively than simply waiting for the platelets to improve on its own,
and if romiplostim will also allow the patient to receive at least 2 further cycles of
chemotherapy without thrombocytopenia.
Clinical Details
Official title: A Randomized Open Label Phase II Study of Romiplostim Versus Observation for Chemotherapy Induced Thrombocytopenia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Achievement of platelet counts of ≥ 100,000/mcL
Secondary outcome: the ability to complete at least two successive cycles of chemotherapy without further evidence of treatment-limiting thrombocytopeniais to evaluate the proportion of patients who cross over and have a subsequent platelet recovery ≥ 100,000/mcL Assessment of potential toxicity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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. 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.
3. Patients with underlying liver disease, such as cirrhosis or chronic hepatitis, will
be excluded if ALT/AST >3X ULN or Total Bili >3X ULN. In the presence of liver
metastasis, but no known cirrhosis or chronic hepatitis, patients will be excluded if
ALT/AST >5X ULN or Total Bili >5X ULN
4. 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. A
venous thrombotic event associated with a central venous catheter will not make the
patient ineligible.
5. 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
6. Pregnant women/lactating mothers
7. Patients unwilling to use contraception.
Locations and Contacts
Gerald Soff, MD, Phone: 212-639-2335
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Not yet recruiting
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Not yet recruiting
Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States; Not yet recruiting Jean Connors, MD
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States; Not yet recruiting
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey 07920, United States; Recruiting Gerald Soff, MD, Phone: 212-639-2335
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States; Recruiting Gerald Soff, MD, Phone: 212-639-2335
Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting Gerald Soff, MD, Phone: 212-639-2335 Gerald Soff, MD, Principal Investigator
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States; Recruiting Gerald Soff, MD, Phone: 212-639-2335
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York 10591, United States; Recruiting Gerald Soff, MD, Phone: 212-639-2335
Memorial Sloan Kettering West Harrison, West Harrison, New York 10604, United States; Recruiting Gerald Soff, MD, Phone: 212-639-2335
Additional Information
Memorial Sloan Kettering Cancer Center
Starting date: January 2014
Last updated: August 17, 2015
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