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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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)


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 NSCLC after
resection or radiation for earlier stage disease

- Measurable or evaluable disease (per modified RECIST)

- Male or female ≥ 18 years of age

- 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 ULN

- AST and 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 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 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 wks 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

- MI within 6 months prior to study entry, uncontrolled CHF; 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 NCI-CTC 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate overall survival with three different regimens of chemotherapy and cetuximab

Outcome Time Frame:

every 3 months

Safety Issue:

No

Principal Investigator

Lee Schwartzberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Accelerated Community Oncology Research Network

Authority:

United States: Institutional Review Board

Study ID:

AC01L08

NCT ID:

NCT00828841

Start Date:

December 2008

Completion Date:

August 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Albany, Georgia  31701
Great Falls, Montana  59405
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Louisville, Kentucky  40207
Little Rock, Arkansas  72205-7199
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
South Burlington, Vermont  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina  
Lebanon, New Hampshire  
Charleston, West Virginia  25304
Sioux Falls, South Dakota  
Family Medicine of Vincennes Vincennes, Indiana