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A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)



- Assess the 3 month progression-free survival rate of the combination of pemetrexed
disodium with bevacizumab in a patient population with stage IIIB (due to pleural
effusion) or IV non-small cell lung cancer.


- Determine the tumor response rate in these patients.

- Determine the effect of pemetrexed disodium in combination with bevacizumab on overall
survival and duration of response in these patients.

- Determine the toxicity profile of this drug regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90
minutes on day 1. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically diagnosed stage IIIB or IV non-small cell lung cancer

- Stage IIIB patients must have pleural effusion

- No symptomatic serosal effusion (grade 2 dyspnea) that is not amenable to

- Mixed histology allowed if all components consistent with non-small cell lung

- Tumors with squamous cell histology feature are allowed

- Must have measurable disease with at least one lesion with a longest diameter
accurately measured as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with
spiral CT

- Large ( > 4 cm) centrally located lesions or large lesions in close proximity to
major blood vessels should receive palliative radiation

- The irradiated lesion should not be a target lesion

- Previously treated with one chemotherapy regimen in the neoadjuvant, adjuvant, or
advanced disease setting

- No symptomatic, untreated, or uncontrolled CNS metastases

- CNS metastases treated with prior whole brain radiotherapy allowed


- ECOG performance status 0-2

- Life expectancy ≥ 12 weeks

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

- Platelet count ≥ 100,000/ mm^3

- Hemoglobin ≥ 9 g/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) or direct bilirubin normal

- AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

- Creatinine clearance ≥ 45 mL/min

- Urine protein:creatinine ratio < 1.0

- Pregnant or nursing women are ineligible

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

- No seizure disorder

- No clinically significant infection

- No other second primary malignancy within the past 5 years except carcinoma in situ
of the cervix, non-melanomatous skin cancer, or low-grade (Gleason score ≤ 6)
localized prostate cancer

- No hypertension or labile hypertension

- No history of poor compliance with antihypertensive medications

- No angina pectoris

- No congestive heart failure within the past 3 months unless ejection fraction > 40%

- No myocardial infarction within the past 6 months

- No cardiac arrhythmia

- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the

- No active or recent history of hemoptysis

- Hemoptysis resolved > 2 weeks ago with measures such as palliative radiation
therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or
endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is

- No diabetes

- No prior serious, non-healing wounds, ulcers, or bone fractures

- No history of stroke within the past 6 months

- No history of abdominal fistula or gastrointestinal perforation

- No intra-abdominal abscess within the past 6 months

- Not at greater than average risk of bleeding

- No significant traumatic injury within the past 4 weeks


- No aspirin at doses ≥ 1.3 grams per day within 10 days prior to or 10 days after
pemetrexed disodium treatment

- No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas)

- No immunotherapy or biologic therapy within the past 2 weeks

- No full field radiation therapy within the past 4 weeks or limited field radiation
therapy within the past 2 weeks

- The site of previous radiotherapy should have evidence of progressive disease if
it is the only site of disease

- No prior post pelvic radiation

- No prior use of pemetrexed disodium

- No prior radiation to > 25% of the marrow cavity

- No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks

- No minor surgery within the past 2 weeks except insertion of a vascular access device

- No concurrent major surgery

- No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any
ancillary therapy considered investigational within the past 4 weeks

- No concurrent use of Hypericum perforatum (St. John's wort)

- No concurrent anticoagulant use

- Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of progression-free patients at 3 months

Safety Issue:


Principal Investigator

Alex A. Adjei, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:




Start Date:

May 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - West Joliet, Illinois  60435
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Foote Hospital Jackson, Michigan  49201
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
CCOP - Duluth Duluth, Minnesota  55805
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Hutchinson Area Health Care Hutchinson, Minnesota  55350
Meeker County Memorial Hospital Lichfield, Minnesota  55355
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Regions Hospital Cancer Care Center St. Paul, Minnesota  55101
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Minnesota Oncology Hematology, PA - Woodbury Woodbury, Minnesota  55125
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Thompson Cancer Survival Center Knoxville, Tennessee  37916
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
St. Mary's - Duluth Clinic Cancer Center Duluth, Minnesota  55805
McCreery Cancer Center at Ottumwa Regional Ottumwa, Iowa  52501
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St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
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Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
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Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Siouxland Regional Cancer Center Sioux City, Iowa  51101-1733
Southwest Medical Center Liberal, Kansas  67901
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grant Riverside Cancer Services Columbus, Ohio  43215
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville, Ohio  43081
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Eden Medical Center Castro Valley, California  94546
Saint Rose Hospital Hayward, California  94545
Highland General Hospital at St. George's University School of Medicine Oakland, California  94602
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Galesburg Clinic Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Capitol Hospital Des Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Green Bay Oncology, Limited - Iron Mountain Iron Mountain, Michigan  49801
Alexandria, Minnesota  56308
MeritCare Clinic - Bemidji Bemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Chippewa County - Montevideo Hospital Montevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Adirondack Cancer Care - Glens Falls Glens Falls, New York  12801
Iredell Memorial Hospital Statesville, North Carolina  28677
Cancer Care Center at Medcenter One Hospital Bismarck, North Dakota  58501
Bismarck Cancer Center Bismarck, North Dakota  58501
St. Alexius Medical Center Bismarck, North Dakota  58502
MeritCare Medical Group Fargo, North Dakota  58122
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
Mercy Medical Center Springfield, Ohio  45504
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Miller-Dwan Medical Center Duluth, Minnesota  55805
Franciscan Skemp Healthcare La Crosse, Wisconsin  54601-4796
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Saint Francis Cancer Center Shakopee, Minnesota  55379
St. Joseph's Hospital St Paul, Minnesota  55102
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Randolph Hospital Asheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro, North Carolina  27401
Annie Penn Cancer Center Reidsville, North Carolina  27320
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
McFarland Clinic, PC Ames, Iowa  50010
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Salem Hospital Regional Cancer Care Services Salem, Oregon  97309-5014
Guthrie Cancer Center at Guthrie Clinic Sayre Sayre, Pennsylvania  18840
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Rutherford Hospital Rutherfordton, North Carolina  28139
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Providence Cancer Center Anchorage, Alaska  99508
Arch Medical Services, Incorporated at Center for Cancer Care Research Saint Louis, Missouri  63141
Billings Clinic Cancer Center Billings, Montana  59107-5100
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Woodwinds Health Campus Woodbury, Minnesota  55125
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens, Michigan  48043
Minnesota Oncology Hematology, PA at Maplewood Cancer Center Maplewood, Minnesota  55109