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Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC

Information source: Accelerated Community Oncology Research Network
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Cetuximab (Drug); Paclitaxel (Drug); Carboplatin (Drug); Gemcitabine (Drug); Cisplatin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Accelerated Community Oncology Research Network

Official(s) and/or principal investigator(s):
Lee Schwartzberg, MD, FACP, Study Chair, Affiliation: Accelerated Community Oncology Research Network

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.

Clinical Details

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

Primary outcome: Overall Survival by Treatment Arm

Secondary outcome:

1-year Survival by Treatment Arm

Overall Survival by Histology

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Anniston, Alabama, United States

Jonesboro, Arkansas, United States

Anaheim, California, United States

Azusa, California, United States

Burbank, California, United States

Campbell, California, United States

Greenbrae, California, United States

Hawthorne, California, United States

Mission Hills, California, United States

Orange, California, United States

Oxnard, California, United States

St. Helena, California, United States

Fort Collins, Colorado, United States

Norwich, Connecticut, United States

Torrington, Connecticut, United States

Trumbull, Connecticut, United States

Fort Lauderdale, Florida, United States

Lake Worth, Florida, United States

Orange City, Florida, United States

Pembroke Pines, Florida, United States

St. Petersburg, Florida, United States

Titusville, Florida, United States

Weston, Florida, United States

Augusta, Georgia, United States

Columbus, Georgia, United States

Lawrenceville, Georgia, United States

Marietta, Georgia, United States

Valdosta, Georgia, United States

Elmhurst, Illinois, United States

Harvey, Illinois, United States

Joliet, Illinois, United States

Quincy, Illinois, United States

Skokie, Illinois, United States

South Bend, Indiana, United States

Family Medicine of Vincennes, Vincennes, Indiana, United States

Arnes, Iowa, United States

Bettendorf, Iowa, United States

Mason City, Iowa, United States

Waterloo, Iowa, United States

Hazard, Kentucky, United States

Louisville, Kentucky, United States

Lafayette, Louisiana, United States

Shreveport, Louisiana, United States

Baltimore, Maryland, United States

Towson, Maryland, United States

Springfield, Massachusetts, United States

Worchester, Massachusetts, United States

Jefferson City, Missouri, United States

St. Joseph, Missouri, United States

St. Louis, Missouri, United States

Billings, Montana, United States

Grand Island, Nebraska, United States

Omaha, Nebraska, United States

Portsmouth, New Hampshire, United States

Bellville, New Jersey, United States

Cherry Hill, New Jersey, United States

Elizabeth, New Jersey, United States

Hackensack, New Jersey, United States

Bronx, New York, United States

East Setauket, New York, United States

Fresh Meadows, New York, United States

Fayetteville, North Carolina, United States

Gastonia, North Carolina, United States

Goldsboro, North Carolina, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Middletown, Ohio, United States

Sandusky, Ohio, United States

Bend, Oregon, United States

Bethlehem, Pennsylvania, United States

Reading, Pennsylvania, United States

Sumter, South Carolina, United States

Sioux Falls, South Dakota, United States

Bristol, Tennessee, United States

Chattanooga, Tennessee, United States

Memphis, Tennessee, United States

Beaumont, Texas, United States

Corpus Christi, Texas, United States

Lubbock, Texas, United States

Bennington, Vermont, United States

Kirkland, Washington, United States

Tacoma, Washington, United States

Huntington, West Virginia, United States

Wauwatosa, Wisconsin, United States

Additional Information

Starting date: December 2008
Last updated: October 11, 2013

Page last updated: August 20, 2015

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