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Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Trial of Pemetrexed in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)


OBJECTIVES:

Primary

- Assess overall survival of patients with selected stage IIIB or IV bronchoalveolar
carcinoma treated with pemetrexed disodium.

Secondary

- Evaluate the progression-free survival of patients treated with this drug.

- Evaluate the response rate (confirmed and unconfirmed, partial and complete) in the
subset of patients with measurable disease treated with this drug using standard RECIST
criteria and computer assisted image analysis.

- Evaluate frequency and severity of toxicities in patients treated with this drug.

- Perform molecular correlative studies on patient tissue to investigate potential
predictors of efficacy. (This will not be completed as this study was closed due to
poor accrual.)

OUTLINE: Patients are stratified according to prior treatment with gefitinib or erlotinib
(yes vs no).

Patients receive pemetrexed disodium intravenous (IV) 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 3 years.

PROJECTED ACCRUAL: A total of 99 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed bronchoalveolar carcinoma (BAC) or BAC variants such as
adenocarcinoma with BAC features or BAC with invasive adenocarcinoma

- Cytology specimens, such as bronchial brushings, washings, or fine needle
aspiration specimens alone are not acceptable for diagnosis

- Stage IV disease OR selected stage IIIB (T4 [secondary to malignant pleural effusion
only], any N, M0) disease

- Incompletely resected or unresectable disease

- Pleural effusions, ascites, or laboratory parameters cannot be only evidence of
disease

- Measurable disease or nonmeasurable disease documented by CT scan

- No known brain metastases

PATIENT CHARACTERISTICS:

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

- SGOT and SGPT ≤ 2.5 times ULN ( ≤ 5 times ULN if due to liver metastases)

- Alkaline phosphatase ≤ 2.5 times ULN ( ≤ 5 times ULN if due to bone metastases)

- Creatinine clearance ≥ 45 mL/min OR creatinine ≤ 1.5 times ULN

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

- Platelet count ≥ 75,000/mm³

- Zubrod 0-2

- No history of allergic reaction to compounds of similar chemical or biological
composition as pemetrexed disodium

- Must provide smoking history

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to swallow pills

PRIOR CONCURRENT THERAPY:

- No more than 2 prior systemic therapies (including epidermal growth factor receptor
inhibitor)

- At least 28 days since prior systemic therapy

- Patients treated with prior erlotinib or gefitinib must have shown progression since
treatment

- No prior pemetrexed disodium

- At least 28 days since prior radiotherapy and recovered

- Must have measurable or nonmeasurable disease outside previously irradiated area
or a new lesion within previously irradiated area

- At least 14 days since prior palliative radiotherapy and recovered

- At least 28 days since prior thoracic or major surgery and recovered

- No concurrent surgery

- No other concurrent therapy (hormonal, biologic or radiotherapy) for this disease

- No concurrent antiretroviral therapy

- Patients should discontinue non-steroidal anti-inflammatory drugs (NSAIDs) with
longer half lives (etodolac, ketordac, sulindac, naproxen, naproxen sodium,
oxaprozin, nabumetone, diflunisal, salsalate, celecoxib, rofecoxib, valdecoxib,
meloxicam, piroxicam) at least 5 days before and for 2 days following pemetrexed
treatment

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome Time Frame:

0 - 3 years

Safety Issue:

No

Principal Investigator

Derick H. Lau, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000456424

NCT ID:

NCT00265785

Start Date:

July 2006

Completion Date:

July 2011

Related Keywords:

  • Lung Cancer
  • bronchoalveolar cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
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 - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
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
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
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
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Mount Carmel Health - West HospitalColumbus, Ohio  43222
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
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
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Denver Health Medical CenterDenver, Colorado  80204-4507
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
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
Northern Montana HospitalHavre, Montana  59501
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
Clinton Memorial HospitalWilmington, Ohio  45177
Adventist Medical CenterPortland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
Hawaii Medical Center - EastHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Maui Memorial Medical CenterWailuku, Hawaii  96793
AnMed Cancer CenterAnderson, South Carolina  29621
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Oregon Health and Science University Cancer InstitutePortland, Oregon  97239-3098
NEA Medical Center - Stadium BoulevardJonesboro, Arkansas  72401