S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

NCT00265785 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000456424U10CA032102S0526
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 112

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with stage III or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

bronchoalveolar cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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.

  0 - 3 years

Secondary Outcomes (3)

• Progression-free Survival

  0 - 3 years

• Response (Confirmed and Unconfirmed, Complete and Partial)

  Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years.

• Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

  Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment.

Study Arms (1)

Pemetrexed

EXPERIMENTAL

pemetrexed

Drug: pemetrexed

Interventions

pemetrexed DRUG

Pemetrexed 500 mg/m\^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.

Also known as: Alimta

Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (112)

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

NEA Medical Center - Stadium Boulevard

Jonesboro, Arkansas, 72401, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

Hawaii Medical Center - East

Honolulu, Hawaii, 96817, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Maui Memorial Medical Center

Wailuku, Hawaii, 96793, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Reid Hospital & Health Care Services

Richmond, Indiana, 47374, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66606, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Northern Montana Hospital

Havre, Montana, 59501, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Mary Rutan Hospital

Bellefontaine, Ohio, 43311, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Medical Center Cancer Care

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Mercy Medical Center

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, 43081, United States

Location

Clinton Memorial Hospital

Wilmington, Ohio, 45177, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Adventist Medical Center

Portland, Oregon, 97216, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center and Children's Hospital

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

AnMed Cancer Center

Anderson, South Carolina, 29621, United States

Location

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, 29401, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Columbia Basin Hematology

Kennewick, Washington, 99336, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Derick H. Lau, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Rachel E. Sanborn, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: July 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 1, 2012
• Results First Posted: November 1, 2012

Record last verified: 2012-10

Locations

US (112)