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A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Randomized Phase II Study of Gemcitabine and Carboplatin With or Without AZD2171 as First-Line Therapy in Advanced Non-Small Cell Lung Cancer



- Assess the objective tumor response rate in patients with stage IIIB or IV non-small
cell lung cancer treated with gemcitabine hydrochloride, carboplatin, and AZD2171 as
first-line therapy.


- Compare the proportion of patients who are progression-free at 6 months after treatment
with gemcitabine hydrochloride and carboplatin with vs without AZD2171.

- Compare the duration of response for responding patients treated with these regimens.

- Compare the time-to-progression and time-to-treatment failure.

- Compare the 1-year overall survival.

- Compare the clinical toxicities.

- Assess the safety and tolerability of these regimens in these patients.


- Collect blood and tumor specimens for future evaluation of pharmacogenetic and
proteomic markers of tumor response and toxicity to therapy with these agents.

- Bank paraffin-embedded tissue blocks/slides and blood samples for future histochemistry
evaluation and DNA extraction.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
adjuvant therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8,
carboplatin IV over 30 minutes on day 1, and oral AZD2171 once daily on days 1-21.
Treatment repeats every 21 days for up to 6 courses. Patients achieving stable disease,
partial response, or complete response after 6 courses of therapy receive AZD2171 alone
as above. Treatment with AZD2171 repeats every 21 days in the absence of disease
progression or unacceptable toxicity.

- Arm II: Patients receive gemcitabine and carboplatin as in arm I. Treatment repeats
every 21 days for up to 6 courses in the absence of disease progression or unacceptable

Patients undergo blood collection periodically during study for pharmacologic correlative

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

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Squamous cell histology allowed

- No mixed histology with small cell component

- Stage IIIB (with pleural effusion) or stage IV disease

- Presence of peritoneal or pericardial effusion alone in the absence of cytologic
evidence is not allowed

- Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by
conventional techniques OR ≥ 1.0 cm by spiral CT scan

- If the only site of measurable disease was previously irradiated, progressive
disease must be evident

- Ineligible for bevacizumab therapy

- No symptomatic, untreated, or uncontrolled CNS metastases

- CNS metastases treated with whole-brain radiation (WBRT) allowed 4 weeks after
completion of WBRT


- ECOG performance status 0-1

- Life expectancy ≥ 12 weeks

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

- Hemoglobin ≥ 9 g/dL

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 3 times upper limit of normal (ULN)

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

- Alkaline phosphatase ≤ 5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception

- No proteinuria ≥ 1+

- No uncontrolled blood pressure (BP), defined as systolic BP > 150 mm Hg and/or
diastolic BP > 100 mm Hg in spite of adequate antihypertensive therapy

- No impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of AZD2171 (e.g., ulcerative disease, uncontrolled
nausea, vomiting, or diarrhea, malabsorption syndrome, or small bowel resection)

- No seizure disorder

- No significant traumatic injury within 4 weeks prior to study entry

- No second primary malignancy except any of the following:

- Carcinoma in situ of the cervix

- Nonmelanoma skin cancer

- Prior malignancy diagnosed and definitively treated ≥ 5 years ago with no
subsequent evidence of recurrence

- History of low-grade (Gleason score ≤ 6) localized prostate cancer even if
diagnosed < 5 years prior to registration

- Treated stage I breast cancer ≤ 5 years prior to registration

- No uncontrolled intercurrent illness, including, but not limited to, any of the

- Ongoing or active infection

- Significant pulmonary symptoms at baseline due to disease

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study

- Baseline hemoptysis

- Cavitating lesions

- No QTc prolongation > 500 msec or other significant ECG abnormality within the past
14 days

- No New York Heart Association class III or IV disease


- See Disease Characteristics

- No prior chemotherapy for advanced lung cancer

- Neoadjuvant or adjuvant therapy for lung cancer within the past 12 months

- More than 12 months since prior immunotherapy and biologic therapy

- More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to
skeletal metastases)

- At least 2 weeks since prior WBRT

- No radiotherapy to ≥ 25% of bone marrow

- No major surgery (i.e., laparotomy) or open biopsy within 4 weeks prior to study
entry (2 weeks for minor surgery)

- Insertion of a vascular access device not considered major or minor surgery

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent grapefruit or grapefruit juice during AZD2171 treatment

- No concurrent drugs or biologics with proarrhythmic potential

- Concurrent palliative radiotherapy to nontarget sites (i.e., painful pre-existing
bony metastasis) allowed with AZD2171 (chemotherapy is held until completion of

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Confirmed tumor response on 2 consecutive evaluations ≥ 4 weeks apart

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:

June 2007

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
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Hurley Medical Center Flint, Michigan  48503
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
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center 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
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical Center Shakopee, Minnesota  55379
HealthEast Cancer Care at St. Joseph's Hospital St Paul, Minnesota  55102
Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
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
HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
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
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Grand Rapids Grand Rapids, Michigan  49503
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
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
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
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
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
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Bettendorf, Iowa  52722
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
Mecosta County Medical Center Big Rapids, Michigan  49307
Immanuel Medical Center Omaha, Nebraska  68122
Creighton University Medical Center Omaha, Nebraska  68131-2197
Bismarck Cancer Center Bismarck, North Dakota  58501
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Franciscan Skemp Healthcare - La Crosse Campus La Crosse, Wisconsin  54601
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Immanuel St. Joseph's Mankato, Minnesota  56002
Mercy Hospital at Wilkes-Barre Wilkes-Barre, Pennsylvania  18765