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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 Center Seattle, Washington  98109
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Hurley Medical Center Flint, Michigan  48503
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
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 - Greenville Greenville, South Carolina  29615
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
University of California Davis Cancer Center Sacramento, California  95817
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
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
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
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
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
Legacy Emanuel Hospital and Health Center and Children's Hospital Portland, Oregon  97227
Mount Carmel Health - West Hospital Columbus, Ohio  43222
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield, Michigan  48075
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
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
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
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Denver Health Medical Center Denver, Colorado  80204-4507
Reid Hospital & Health Care Services Richmond, Indiana  47374
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
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
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
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland, Oregon  97210
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Maui Memorial Medical Center Wailuku, Hawaii  96793
AnMed Cancer Center Anderson, South Carolina  29621
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Oregon Health and Science University Cancer Institute Portland, Oregon  97239-3098
NEA Medical Center - Stadium Boulevard Jonesboro, Arkansas  72401