Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00413283

Last Updated: 2013-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-02-28

Brief Summary

The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.

Conditions

Lung Cancer; Chemotherapy-Induced Thrombocytopenia; Non-Small Cell Lung Cancer; Cancer; Lung Neoplasms; Oncology; Solid Tumors; Thrombocytopenia

Keywords

Advanced Non-Small Cell Lung Cancer; Chemotherapy Induced Thrombocytopenia; CIT; NSCLC; Stage IIIB NSCLC; Stage IV NSCLC; Gemcitabine; Carboplatin; Cisplatin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo subcutaneous injection.

Gemcitabine

Intervention Type: DRUG

Intravenous infusion

Carboplatin

Intervention Type: DRUG

Intravenous infusion

Cisplatin

Intervention Type: DRUG

Intravenous infusion

Romiplostim 250 μg

Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: BIOLOGICAL

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Gemcitabine

Intervention Type: DRUG

Intravenous infusion

Carboplatin

Intervention Type: DRUG

Intravenous infusion

Cisplatin

Intervention Type: DRUG

Intravenous infusion

Romiplostim 500 μg

Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: BIOLOGICAL

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Gemcitabine

Intervention Type: DRUG

Intravenous infusion

Carboplatin

Intervention Type: DRUG

Intravenous infusion

Cisplatin

Intervention Type: DRUG

Intravenous infusion

Romiplostim 750 μg

Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.

Group Type: EXPERIMENTAL

Romiplostim

Intervention Type: BIOLOGICAL

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Gemcitabine

Intervention Type: DRUG

Intravenous infusion

Carboplatin

Intervention Type: DRUG

Intravenous infusion

Cisplatin

Intervention Type: DRUG

Intravenous infusion

Interventions

Romiplostim

Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production.

Intervention Type: BIOLOGICAL

Placebo

Placebo subcutaneous injection.

Intervention Type: DRUG

Gemcitabine

Intravenous infusion

Intervention Type: DRUG

Carboplatin

Intravenous infusion

Intervention Type: DRUG

Cisplatin

Intravenous infusion

Intervention Type: DRUG

Other Intervention Names

AMG 531; Nplate®

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed locally advanced or metastatic stage IIIB or stage IV NSCLC receiving 21-day cycles of gemcitabine/carboplatin or gemcitabine/cisplatin
• Life expectancy ≥ 12 weeks at the time of screening
• Thrombocytopenia as evidenced by a platelet count ≤ 50 x 10^9/L during the qualifying cycle of chemotherapy, OR platelet count < 100 x 10^9/L on Day 22 of the qualifying cycle (for eligibility inclusion: ability to receive the same dose of chemotherapy on study), this criteria ensures that the patient must be dose delayed for platelet recovery
• Ability to receive the same dose and schedule of chemotherapy during the first on-study treatment cycle as was given in the qualifying cycle (except Day 8 gemcitabine)
• Absolute neutrophil count (ANC) ≥ 1,000/µL, hemoglobin ≥ 9.5 g/dL, and platelet count ≥ 100 x 10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at the time of screening
• Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) (except for patients with a confirmed diagnosis of Gilbert's Syndrome)
• Adequate renal function; serum creatinine < 1.5 x ULN

Exclusion Criteria

• Receipt of > 1 prior systemic chemotherapy regimen
• Sepsis, disseminated coagulation or any other condition (i.e. immune [idiopathic] thrombocytopenic purpura [ITP], thrombotic thrombocytopenic purpura [TTP], hemolytic uremic syndrome [HUS]) that may exacerbate thrombocytopenia
• History of unstable angina, congestive heart failure, uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year of screening ) myocardial infarction
• History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening
• History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots)
• Use of any nitrosourea or mitomycin-C within 6 weeks of screening
• Have received any thrombopoietic growth factor or related substance
• Have received granulocyte macrophage colony stimulating factor (GM-CSF) within the last 4 weeks prior to screening
• Have received any experimental therapy within 4 weeks prior to screening
• Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening)
• Known hypersensitivity to any recombinant E. coli-derived product.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

Glendale, Arizona, United States

Research Site

Glendale, Arizona, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Rancho Mirage, California, United States

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Rancho Mirage, California, United States

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Boynton Beach, Florida, United States

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Boynton Beach, Florida, United States

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Vero Beach, Florida, United States

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Vero Beach, Florida, United States

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Athens, Georgia, United States

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Athens, Georgia, United States

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Macon, Georgia, United States

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Macon, Georgia, United States

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Peoria, Illinois, United States

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Peoria, Illinois, United States

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Sioux City, Iowa, United States

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Sioux City, Iowa, United States

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Paducah, Kentucky, United States

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Paducah, Kentucky, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Sterling Heights, Michigan, United States

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Sterling Heights, Michigan, United States

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Billings, Montana, United States

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Billings, Montana, United States

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Flemington, New Jersey, United States

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Flemington, New Jersey, United States

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Johnson City, New York, United States

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Johnson City, New York, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Drexel Hill, Pennsylvania, United States

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Drexel Hill, Pennsylvania, United States

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Dunmore, Pennsylvania, United States

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Dunmore, Pennsylvania, United States

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Radnor, Pennsylvania, United States

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Radnor, Pennsylvania, United States

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Columbia, South Carolina, United States

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Columbia, South Carolina, United States

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Germantown, Tennessee, United States

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Germantown, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Graz, , Austria

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Graz, , Austria

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Innsbruck, , Austria

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Innsbruck, , Austria

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Klagenfurt, , Austria

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Klagenfurt, , Austria

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Linz, , Austria

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Linz, , Austria

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Rankweil, , Austria

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Rankweil, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Toronto, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Sainte-Foy, Quebec, Canada

Research Site

Sainte-Foy, Quebec, Canada

Research Site

Bad Berka, , Germany

Research Site

Bad Berka, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Halle, , Germany

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Halle, , Germany

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Hemer, , Germany

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Hemer, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Edelény, , Hungary

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Edelény, , Hungary

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Gyula, , Hungary

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Gyula, , Hungary

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Mátraháza, , Hungary

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Mátraháza, , Hungary

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Pécs, , Hungary

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Pécs, , Hungary

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Székesfehérvár, , Hungary

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Székesfehérvár, , Hungary

Research Site

Törökbálint, , Hungary

Research Site

Törökbálint, , Hungary

Research Site

Zalaegerszeg - Pozva, , Hungary

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Zalaegerszeg - Pozva, , Hungary

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Cork, , Ireland

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Cork, , Ireland

Research Site

Dublin, , Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Novara, , Italy

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Novara, , Italy

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Orbassano, , Italy

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Orbassano, , Italy

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Palermo, , Italy

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Palermo, , Italy

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Torino, , Italy

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Torino, , Italy

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Coimbra, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

Research Site

Vila Nova de Gaia, , Portugal

Research Site

Vila Nova de Gaia, , Portugal

Countries

United States; Austria; Canada; Germany; Hungary; Ireland; Italy; Portugal

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20050154

Identifier Type: -

Identifier Source: org_study_id