Clinical trial NCT00828841: Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC
Official title: A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Accelerated Community Oncology Research Network
Sponsor class: OTHER
First posted: 2009-01-26
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.


Eligibility criteria: Inclusion Criteria:

* Written informed consent before study-related activities
* Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung cancer (NSCLC) after resection or radiation for earlier stage disease
* Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] guidelines)
* Male or female ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100 x 10(9)/L, and hemoglobin ≥ 9.5 g/dL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver mets
* Serum creatinine ≤ 1.25 x ULN
* Recovery from prior surgery or radiation to Grade 1 or better toxicity
* Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized
* WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test during screening or prior to study drug administration
* Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential
* Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry
* Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed \> 30 days prior to randomization
* Treatment with any investigational agent(s) within 4 weeks prior to study entry
* Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy
* Carcinoid, atypical carcinoid or small cell lung cancer
* Symptomatic or uncontrolled mets in the central nervous system
* Prior invasive malignancy requiring ongoing therapy within the past year
* Active infection (infection requiring intravenous \[IV\] antibiotics), including active tuberculosis, known and declared HIV
* Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment
* Known allergic/hypersensitivity reaction to any of the components of study treatments
* Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for Adverse Events, version 3.0
* History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder
* Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
* Known drug abuse

Patients of all races and ethnic groups are eligible for this trial.

Primary outcomes:
measure: Overall Survival by Treatment Arm
timeFrame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Secondary outcomes:
measure: 1-year Survival by Treatment Arm
timeFrame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
measure: Overall Survival by Histology
timeFrame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Jonesboro
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Azusa
country: United States
state: California
city: Burbank
country: United States
state: California
city: Campbell
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: Hawthorne
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Orange
country: United States
state: California
city: Oxnard
country: United States
state: California
city: St. Helena
country: United States
state: California
city: Fort Collins
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Torrington
country: United States
state: Connecticut
city: Trumbull
country: United States
state: Connecticut
city: Fort Lauderdale
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Titusville
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Lawrenceville
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Valdosta
country: United States
state: Georgia
city: Elmhurst
country: United States
state: Illinois
city: Harvey
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Quincy
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Vincennes
country: United States
facility: Family Medicine of Vincennes
state: Indiana
city: Arnes
country: United States
state: Iowa
city: Bettendorf
country: United States
state: Iowa
city: Mason City
country: United States
state: Iowa
city: Waterloo
country: United States
state: Iowa
city: Hazard
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Worchester
country: United States
state: Massachusetts
city: Jefferson City
country: United States
state: Missouri
city: St. Joseph
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Grand Island
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Portsmouth
country: United States
state: New Hampshire
city: Bellville
country: United States
state: New Jersey
city: Cherry Hill
country: United States
state: New Jersey
city: Elizabeth
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: East Setauket
country: United States
state: New York
city: Fresh Meadows
country: United States
state: New York
city: Fayetteville
country: United States
state: North Carolina
city: Gastonia
country: United States
state: North Carolina
city: Goldsboro
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Sandusky
country: United States
state: Ohio
city: Bend
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Sumter
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Beaumont
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
city: Kirkland
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: Wauwatosa
country: United States
state: Wisconsin
Study officials:
affiliation: Accelerated Community Oncology Research Network
name: Lee Schwartzberg, MD, FACP
role: STUDY_CHAIR
References: