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

NCT00828841 | Completed Phase 2 Results DMC

• 1 other identifier: AC01L08
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 84

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival by Treatment Arm

  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 (2)

• 1-year Survival by Treatment Arm

  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.

• Overall Survival by Histology

  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.

Study Arms (3)

Paclitaxel, Carboplatin, Cetuximab (Arm A)

ACTIVE COMPARATOR

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.

Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin

Platinum, Gemcitabine, Cetuximab (Arm B)

ACTIVE COMPARATOR

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.

Drug: Cetuximab; Drug: Carboplatin; Drug: Gemcitabine; Drug: Cisplatin

Platinum, Pemetrexed, Cetuximab (Arm C)

ACTIVE COMPARATOR

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.

Drug: Cetuximab; Drug: Carboplatin; Drug: Cisplatin

Interventions

Cetuximab DRUG

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.

Also known as: Erbitux

Paclitaxel, Carboplatin, Cetuximab (Arm A); Platinum, Gemcitabine, Cetuximab (Arm B); Platinum, Pemetrexed, Cetuximab (Arm C)

Paclitaxel DRUG

Paclitaxel 200 mg/m2 Day 1 every 21 days

Also known as: Taxol

Paclitaxel, Carboplatin, Cetuximab (Arm A)

Carboplatin DRUG

Carboplatin AUC 6 Day 1 every 21 days

Also known as: Paraplatin

Paclitaxel, Carboplatin, Cetuximab (Arm A); Platinum, Gemcitabine, Cetuximab (Arm B); Platinum, Pemetrexed, Cetuximab (Arm C)

Gemcitabine DRUG

Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days

Also known as: Gemzar

Platinum, Gemcitabine, Cetuximab (Arm B)

Cisplatin DRUG

Cisplatin 75 mg/m2 Day I every 21 days

Also known as: Platinol

Platinum, Gemcitabine, Cetuximab (Arm B); Platinum, Pemetrexed, Cetuximab (Arm C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accelerated Community Oncology Research Network: lead

Study Sites (84)

Unknown Facility

Anniston, Alabama, United States

Location

Unknown Facility

Jonesboro, Arkansas, United States

Location

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Azusa, California, United States

Location

Unknown Facility

Burbank, California, United States

Location

Unknown Facility

Campbell, California, United States

Location

Unknown Facility

Greenbrae, California, United States

Location

Unknown Facility

Hawthorne, California, United States

Location

Unknown Facility

Mission Hills, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Oxnard, California, United States

Location

Unknown Facility

St. Helena, California, United States

Location

Unknown Facility

Fort Collins, Colorado, United States

Location

Unknown Facility

Norwich, Connecticut, United States

Location

Unknown Facility

Torrington, Connecticut, United States

Location

Unknown Facility

Trumbull, Connecticut, United States

Location

Unknown Facility

Fort Lauderdale, Florida, United States

Location

Unknown Facility

Lake Worth, Florida, United States

Location

Unknown Facility

Orange City, Florida, United States

Location

Unknown Facility

Pembroke Pines, Florida, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Titusville, Florida, United States

Location

Unknown Facility

Weston, Florida, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Columbus, Georgia, United States

Location

Unknown Facility

Lawrenceville, Georgia, United States

Location

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Valdosta, Georgia, United States

Location

Unknown Facility

Elmhurst, Illinois, United States

Location

Unknown Facility

Harvey, Illinois, United States

Location

Unknown Facility

Joliet, Illinois, United States

Location

Unknown Facility

Quincy, Illinois, United States

Location

Unknown Facility

Skokie, Illinois, United States

Location

Unknown Facility

South Bend, Indiana, United States

Location

Family Medicine of Vincennes

Vincennes, Indiana, United States

Location

Unknown Facility

Arnes, Iowa, United States

Location

Unknown Facility

Bettendorf, Iowa, United States

Location

Unknown Facility

Mason City, Iowa, United States

Location

Unknown Facility

Waterloo, Iowa, United States

Location

Unknown Facility

Hazard, Kentucky, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Lafayette, Louisiana, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Towson, Maryland, United States

Location

Unknown Facility

Springfield, Massachusetts, United States

Location

Unknown Facility

Worchester, Massachusetts, United States

Location

Unknown Facility

Jefferson City, Missouri, United States

Location

Unknown Facility

Saint Joseph, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Billings, Montana, United States

Location

Unknown Facility

Grand Island, Nebraska, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Portsmouth, New Hampshire, United States

Location

Unknown Facility

Bellville, New Jersey, United States

Location

Unknown Facility

Cherry Hill, New Jersey, United States

Location

Unknown Facility

Elizabeth, New Jersey, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

East Setauket, New York, United States

Location

Unknown Facility

Fresh Meadows, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Fayetteville, North Carolina, United States

Location

Unknown Facility

Gastonia, North Carolina, United States

Location

Unknown Facility

Goldsboro, North Carolina, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Dayton, Ohio, United States

Location

Unknown Facility

Middletown, Ohio, United States

Location

Unknown Facility

Sandusky, Ohio, United States

Location

Unknown Facility

Bend, Oregon, United States

Location

Unknown Facility

Bethlehem, Pennsylvania, United States

Location

Unknown Facility

Reading, Pennsylvania, United States

Location

Unknown Facility

Sumter, South Carolina, United States

Location

Unknown Facility

Sioux Falls, South Dakota, United States

Location

Unknown Facility

Bristol, Tennessee, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Beaumont, Texas, United States

Location

Unknown Facility

Corpus Christi, Texas, United States

Location

Unknown Facility

Lubbock, Texas, United States

Location

Unknown Facility

Bennington, Vermont, United States

Location

Unknown Facility

Kirkland, Washington, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

Unknown Facility

Huntington, West Virginia, United States

Location

Unknown Facility

Wauwatosa, Wisconsin, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cetuximab; Paclitaxel; Carboplatin; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Vice President of Scientific Affairs
• Organization: Accelerated Community Oncology Research Network, Inc.

mwalker@acorncro.com

Study Officials

• Lee Schwartzberg, MD, FACP

  Accelerated Community Oncology Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: December 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 6, 2013
• Results First Posted: October 11, 2013

Record last verified: 2013-10

Locations

US (84)