Study of Romiplostim Versus Observation for Chemotherapy Induced Thrombocytopenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02052882
First received: January 30, 2014
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Isolated Chemotherapy-induced Thrombocytopenia
Biological: romiplostim,
Other: Control cohort
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open Label Phase II Study of Romiplostim Versus Observation for Chemotherapy Induced Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Achievement of platelet counts of ≥ 100,000/mcL [ Time Frame: within 3 weeks after treatment ] [ Designated as safety issue: No ]
    The primary therapeutic response is assessed by the platelet count within 3 weeks of treatment.


Secondary Outcome Measures:
  • the ability to complete at least two successive cycles of chemotherapy without further evidence of treatment-limiting thrombocytopenia [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    For patients who successfully achieve platelet counts of ≥ 100,000/mcL, and resume chemotherapy. This will be based on the platelet counts at the completion of the third week of initial treatment as well as the platelet counts at the beginning and end of the two subsequent chemotherapy cycles.

  • is to evaluate the proportion of patients who cross over and have a subsequent platelet recovery ≥ 100,000/mcL [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Patients in the control arm who do not achieve a spontaneous platelet recovery will be allowed to cross over and receive romiplostim. To evaluate the proportion of patients who cross over and have a subsequent platelet recovery ≥ 100,000/mcL

  • Assessment of potential toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Assessment of potential toxicity will be based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Romiplostim
All patients randomized to the experimental arm 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.
Biological: romiplostim,
Control Cohort
Patients will be monitored with weekly CBCs, after enrollment. Supportive transfusion will not be withheld if considered necessary, but will result in removal from the study. If patients in the control cohort do not spontaneously achieve adequate platelet correction >100,000/mcL by the 3-week primary endpoint, they can then be crossed-over to romiplostim treatment. For those patients who cross-over to romiplostim, monitoring and romiplostim dose titration is to be performed as above for the initial romiplostim cohort.
Other: Control cohort
If patients in the control cohort do not spontaneously achieve adequate platelet correction >100,000/mcL by the 3-week primary endpoint, they can then be crossed-over to romiplostim treatment. For those patients who cross-over to romiplostim, monitoring and romiplostim dose titration is to be performed as above for the initial romiplostim cohort.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 in the prior 2 months without evidence of leukemia or myelodysplasia by fluorescent in situ-hybridization (FISH)FISH. In the event that a bone marrow aspirate attempt is unsuccessful, (referred to as a "Dry Tap"), fluorescent in situ-hybridization (FISH) to rule out leukemia or myelodysplasia will be performed from peripheral blood.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052882

Contacts
Contact: Gerald Soff, MD 212-639-2335
Contact: Rekha Parameswaran, MD 212-639-4812

Locations
United States, New Jersey
Memorial Sloan Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Gerald Soff, MD    212-639-2335      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Gerald Soff, MD    212-639-2335      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Gerald Soff, MD    212-639-2335      
Principal Investigator: Gerald Soff, MD         
Memorial Sloan Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Gerald Soff, MD    212-639-2335      
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Gerald Soff, MD    212-639-2335      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Amgen
Investigators
Principal Investigator: Gerald Soff, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02052882     History of Changes
Other Study ID Numbers: 13-132
Study First Received: January 30, 2014
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Romiplostim
Thrombocytopenia
13-132

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014