Isolated Chemotherapy-induced Thrombocytopenia
Conditions
Keywords
Romiplostim, Thrombocytopenia, 13-132
Brief 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.
Interventions
BIOLOGICALromiplostim
Sponsors
Amgen
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL | within 3 weeks after treatment | The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Evaluated for Toxicity | 1 year | Assessment of toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Romiplostim All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy.
Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel.
romiplostim | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inadequate testing | 1 |
| Overall Study | Not treated | 11 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Romiplostim |
|---|---|
| Age, Continuous | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 53 / 60 |
| other Total, other adverse events | 6 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL
The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment.
Time frame: within 3 weeks after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Romiplostim | Percentage of Participants Who Achieved Platelet Counts of ≥ 100,000/mcL | 93 percentage of participants |
Secondary
Number of Participants Evaluated for Toxicity
Assessment of toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Romiplostim | Number of Participants Evaluated for Toxicity | 60 Participants |