Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC
NCT ID: NCT00828841
Last Updated: 2013-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
601 participants
INTERVENTIONAL
2008-12-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Paclitaxel, Carboplatin, Cetuximab (Arm A)
Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Paclitaxel
Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Platinum, Gemcitabine, Cetuximab (Arm B)
Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Gemcitabine
Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Platinum, Pemetrexed, Cetuximab (Arm C)
Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Interventions
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Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Paclitaxel
Paclitaxel 200 mg/m2 Day 1 every 21 days
Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Gemcitabine
Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Accelerated Community Oncology Research Network
OTHER
Responsible Party
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Principal Investigators
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Lee Schwartzberg, MD, FACP
Role: STUDY_CHAIR
Accelerated Community Oncology Research Network
Locations
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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
Saint 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
East Setauket, New York, United States
Fresh Meadows, New York, United States
The Bronx, 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
Countries
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Other Identifiers
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AC01L08
Identifier Type: -
Identifier Source: org_study_id