Clinical trial NCT00413283: Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 For Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Advanced Non-Small Cell Lung Cancer Already Receiving Gemcitabine and Platinum.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 4 months
Secondary outcomes:
measure: Duration of Grade 3 or 4 Thrombocytopenia
timeFrame: 3 weeks
measure: Number of Participants Experiencing Grade 3 or 4 Thrombocytopenia During the First Treatment Cycle.
timeFrame: 3 weeks
measure: Number of Participants With Platelet Transfusions
timeFrame: 3 weeks
measure: Platelet Count on Day 22
timeFrame: Day 22
measure: Gemcitabine Dose Reduction on Day 8 of the First Chemotherapy Cycle
timeFrame: 8 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Anaheim
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Vero Beach
country: United States
facility: Research Site
state: Florida
city: Vero Beach
country: United States
facility: Research Site
state: Florida
city: Athens
country: United States
facility: Research Site
state: Georgia
city: Athens
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: Sioux City
country: United States
facility: Research Site
state: Iowa
city: Sioux City
country: United States
facility: Research Site
state: Iowa
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Sterling Heights
country: United States
facility: Research Site
state: Michigan
city: Sterling Heights
country: United States
facility: Research Site
state: Michigan
city: Billings
country: United States
facility: Research Site
state: Montana
city: Billings
country: United States
facility: Research Site
state: Montana
city: Flemington
country: United States
facility: Research Site
state: New Jersey
city: Flemington
country: United States
facility: Research Site
state: New Jersey
city: Johnson City
country: United States
facility: Research Site
state: New York
city: Johnson City
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Drexel Hill
country: United States
facility: Research Site
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Research Site
state: Pennsylvania
city: Dunmore
country: United States
facility: Research Site
state: Pennsylvania
city: Dunmore
country: United States
facility: Research Site
state: Pennsylvania
city: Radnor
country: United States
facility: Research Site
state: Pennsylvania
city: Radnor
country: United States
facility: Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Germantown
country: United States
facility: Research Site
state: Tennessee
city: Germantown
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Graz
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Rankweil
country: Austria
facility: Research Site
city: Rankweil
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: Research Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Research Site
state: Quebec
city: Bad Berka
country: Germany
facility: Research Site
city: Bad Berka
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Halle/ Saale
country: Germany
facility: Research Site
city: Halle/ Saale
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Edeleny
country: Hungary
facility: Research Site
city: Edeleny
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Matrahaza
country: Hungary
facility: Research Site
city: Matrahaza
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
city: Zalaegerszeg - Pozva
country: Hungary
facility: Research Site
city: Zalaegerszeg - Pozva
country: Hungary
facility: Research Site
city: Cork
country: Ireland
facility: Research Site
city: Cork
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Dublin
country: Ireland
facility: Research Site
city: Novara
country: Italy
facility: Research Site
city: Novara
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: