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A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Combination Carboplatin, Paclitaxel, Cetuximab and Bevacizumab (NSC-704865) Followed By Cetuximab and Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- Evaluate the frequency and severity of hemorrhage toxicities in patients with advanced
non-small cell lung cancer treated with induction therapy comprising cetuximab,
paclitaxel, carboplatin, and bevacizumab followed by maintenance therapy comprising
cetuximab and bevacizumab.

Secondary

- Evaluate progression-free and overall survival and response rates (confirmed and
unconfirmed, complete and partial) in patients treated with this regimen.

- Determine the frequency and severity of nonhemorrhage toxicities in patients treated
with this regimen.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15
and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over
30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the
absence of disease progression or unacceptable toxicity.

- Maintenance therapy: Patients receive cetuximab IV over 1 hour on days 1, 8, and 15 and
bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced primary non-small cell lung cancer
(NSCLC) meeting 1 of the following criteria:

- Newly diagnosed selected stage IIIB disease

- T4 lesion due to malignant pleural effusion

- Any N

- M0

- Newly diagnosed stage IV disease

- Any T

- Any N

- M1 (i.e., distant metastases present)

- Recurrent disease after prior surgery and/or radiotherapy (considered stage IV
disease)

- Any 1 of the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Unspecified

- No tumor with > 50% squamous cell components

- Measurable or nonmeasurable disease as measured by CT scan, MRI, x-ray, or physical
exam

- Disease must be outside the previous radiation field, area of surgical
resection, or a new lesion must be present

- Pleural effusions, ascites, or laboratory parameters are not acceptable as the
only evidence of disease

- No known brain metastases

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Hemoglobin ≥ 9 mg/dL

- Creatinine normal

- Creatinine clearance ≥ 50 mL/min

- Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine
collection

- SGOT or SGPT ≤ 2 times upper limit of normal (ULN)

- Bilirubin ≤ 2 times ULN

- Alkaline phosphatase ≤ 2 times ULN

- INR ≤ 1.5

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after completion of study treatment

- No symptomatic neuropathy (sensory) ≥ grade 2

- No documented evidence of acute hepatitis

- No active or uncontrolled infection

- No history of any of the following:

- Cerebral vascular accident within the past 6 months

- Myocardial infarction within the past 6 months

- Unstable angina within the past 6 months

- Uncontrolled hypertension

- New York Heart Association class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Clinically significant peripheral vascular disease

- No serious or nonhealing wound, ulcer, or bone fracture

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- No hemoptysis ≥ ½ teaspoon within the past 3 months

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- No significant traumatic injury within the past 28 days

- No evidence of bleeding diathesis or coagulopathy

- No other prior malignancy within the past 5 years except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer for which the patient is currently in
complete remission

- No documented presence of human anti-mouse antibodies (HAMA)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior therapy

- At least 3 weeks since prior radiotherapy

- At least 4 weeks since prior surgery (e.g., thoracic or other major surgery) and no
anticipated need for surgery during study treatment

- At least 28 days since prior open biopsy

- At least 7 days since prior core biopsy

- No prior systemic chemotherapy or biologic therapy for NSCLC

- No prior adjuvant therapy for NSCLC

- No prior cetuximab, gefitinib, erlotinib, or other investigational agents that target
the epidermal growth factor receptor (EGFR) pathway

- No prior vascular endothelial growth factor (VEGF)-related agents

- No prior chimerized or murine monoclonal antibody therapy

- No concurrent full-dose anticoagulation therapy

- Concurrent low-dose (1 mg daily) warfarin allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and severity of hemorrhage toxicities

Safety Issue:

Yes

Principal Investigator

Edward S. Kim

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000495363

NCT ID:

NCT00368992

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Eden Medical CenterCastro Valley, California  94546
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
Poudre Valley HospitalFort Collins, Colorado  80524
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Edward Hospital Cancer CenterNaperville, Illinois  60540
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
Mercy Medical CenterSpringfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Highland General HospitalOakland, California  94602
Northeast Georgia Medical CenterGainesville, Georgia  30501
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Adventist Medical CenterPortland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
Salem Hospital Regional Cancer Care ServicesSalem, Oregon  97309-5014
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
St. John's Regional Medical CenterJoplin, Missouri  64804
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
East Bay Radiation Oncology CenterCastro Valley, California  94546
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
Valley Medical Oncology Consultants - PleasantonPleasanton, California  94588
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
Regional Medical CenterAnniston, Alabama  36202
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538