- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00227565
Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with carboplatin works in treating patients with extensive-stage small cell lung cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with previously untreated, extensive-stage small cell lung cancer treated with pemetrexed disodium and carboplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine, preliminarily, the survival of patients treated with this regimen.
- Determine, preliminarily, the response rate in patients 70 years and older treated with this regimen.
- Determine, preliminarily, the toxicity of this regimen in patients 70 years and older.
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 70 years vs ≥ 70 years).
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: Approximately 77 patients at least 46 who are < 70 years of age and at least 24 who are ≥ 70 years of age) will be accrued for this study within 20-26 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic Scottsdale
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Colorado
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Aurora, Colorado, United States, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, United States, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, United States, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, United States, 80210
- Porter Adventist Hospital
-
Denver, Colorado, United States, 80220
- Rose Medical Center
-
Denver, Colorado, United States, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, United States, 80204
- St. Anthony Central Hospital
-
Denver, Colorado, United States, 80218
- St. Joseph Hospital
-
Denver, Colorado, United States, 80224-2522
- CCOP - Colorado Cancer Research Program
-
Englewood, Colorado, United States, 80110
- Swedish Medical Center
-
Grand Junction, Colorado, United States, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
-
Greeley, Colorado, United States, 80631
- North Colorado Medical Center
-
Lone Tree, Colorado, United States, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, United States, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, United States, 80539
- McKee Medical Center
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Pueblo, Colorado, United States, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, United States, 80229
- North Suburban Medical Center
-
Wheat Ridge, Colorado, United States, 80033
- Exempla Lutheran Medical Center
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic - Jacksonville
-
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Illinois
-
Aurora, Illinois, United States, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, United States, 61701
- St. Joseph Medical Center
-
Canton, Illinois, United States, 61520
- Graham Hospital
-
Carthage, Illinois, United States, 62321
- Memorial Hospital
-
Eureka, Illinois, United States, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Clinic, PC
-
Havana, Illinois, United States, 62644
- Mason District Hospital
-
Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
-
Kewanee, Illinois, United States, 61443
- Kewanee Hospital
-
Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
-
Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, United States, 61761
- Community Cancer Center
-
Ottawa, Illinois, United States, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, United States, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
-
Pekin, Illinois, United States, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, United States, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61614
- Proctor Hospital
-
Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, United States, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, United States, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
-
Peru, Illinois, United States, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, United States, 61362
- St. Margaret's Hospital
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Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
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Indiana
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Beech Grove, Indiana, United States, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
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Kokomo, Indiana, United States, 46904
- Howard Community Hospital
-
La Porte, Indiana, United States, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
-
Michigan City, Indiana, United States, 46360
- Saint Anthony Memorial Health Centers
-
Richmond, Indiana, United States, 47374
- Reid Hospital & Health Care Services
-
South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, United States, 46601
- CCOP - Northern Indiana CR Consortium
-
South Bend, Indiana, United States, 46617
- Saint Joseph Regional Medical Center
-
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Iowa
-
Ames, Iowa, United States, 50010
- McFarland Clinic, PC
-
Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Associates
-
Des Moines, Iowa, United States, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, United States, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, United States, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, United States, 50307
- Mercy Capitol Hospital
-
Mason City, Iowa, United States, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Sioux City, Iowa, United States, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, United States, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, United States, 51104
- Mercy Medical Center - Sioux City
-
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Michigan
-
Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
-
Dearborn, Michigan, United States, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, United States, 49431
- Green Bay Oncology, Limited - Escanaba
-
Flint, Michigan, United States, 48503
- Hurley Medical Center
-
Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, United States, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, United States, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, United States, 49201
- Foote Memorial Hospital
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Lansing, Michigan, United States, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, United States, 48154
- St. Mary Mercy Hospital
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Pontiac, Michigan, United States, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, United States, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, United States, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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St. Joseph, Michigan, United States, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Warren, Michigan, United States, 48093
- St. John Macomb Hospital
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Minnesota
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Albert Lea, Minnesota, United States, 56007
- Albert Lea Cancer Center at Albert Lea Medical Center
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Bemidji, Minnesota, United States, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, United States, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
-
Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Duluth, Minnesota, United States, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, United States, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, United States, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, United States, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
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Lichfield, Minnesota, United States, 55355
- Meeker County Memorial Hospital
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology, PA - Maplewood
-
Maplewood, Minnesota, United States, 55109
- HealthEast Cancer Care at St. John's Hospital
-
Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, United States, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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Shakopee, Minnesota, United States, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St Paul, Minnesota, United States, 55102
- HealthEast Cancer Care at St. Joseph's Hospital
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St. Louis Park, Minnesota, United States, 55416
- Park Nicollet Cancer Center
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St. Paul, Minnesota, United States, 55102
- United Hospital
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St. Paul, Minnesota, United States, 55101
- Regions Hospital Cancer Care Center
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Woodbury, Minnesota, United States, 55125
- HealthEast Cancer Care at Woodwinds Health Campus
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North Carolina
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Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
-
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North Dakota
-
Bismarck, North Dakota, United States, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, United States, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, United States, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, United States, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, United States, 58122
- MeritCare Broadway
-
Grand Forks, North Dakota, United States, 58201
- Altru Cancer Center at Altru Hospital
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Ohio
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Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, United States, 45405
- Grandview Hospital
-
Dayton, Ohio, United States, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, United States, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, United States, 45429
- CCOP - Dayton
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Findlay, Ohio, United States, 45840
- Blanchard Valley Medical Associates
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Kettering, Ohio, United States, 45429
- Charles F. Kettering Memorial Hospital
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Middletown, Ohio, United States, 45044
- Middletown Regional Hospital
-
Troy, Ohio, United States, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Xenia, Ohio, United States, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
-
Allentown, Pennsylvania, United States, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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Danville, Pennsylvania, United States, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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State College, Pennsylvania, United States, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, United States, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Carolina
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Anderson, South Carolina, United States, 29621
- AnMed Cancer Center
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, United States, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, United States, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Wisconsin
-
Green Bay, Wisconsin, United States, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, United States, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, United States, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, United States, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Marinette, Wisconsin, United States, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Oconto Falls, Wisconsin, United States, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, United States, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
- Previously untreated disease
- No mixed histology
Extensive-stage disease
- Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
No symptomatic, untreated, or uncontrolled CNS metastases
- CNS metastases previously treated with whole-brain radiotherapy allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
Hepatic
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR
- Direct bilirubin normal
- ALT and AST ≤ 3 times ULN (5 times ULN if there is liver involvement)
Renal
- Creatinine clearance ≥ 45 mL/min
Cardiovascular
- No angina pectoris
- No congestive heart failure within the past 3 months, unless ejection fraction > 40%
- No cardiac arrhythmia
- No myocardial infarction within the past 3 months
- No hypertension, including labile hypertension
Pulmonary
- No interstitial pneumonia
- No extensive and symptomatic interstitial fibrosis of the lung
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of poor compliance with antihypertensive medication
- Able to take folic acid, cyanocobalamin (vitamin B_12) supplementation, or dexamethasone
- No uncontrolled diabetes
- No serious condition that would preclude study participation
- No clinically significant infection
- No significant traumatic injury
No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
- Low-grade (Gleason score ≤ 6), localized prostate cancer allowed even if diagnosed < 5 years prior to study entry
- No seizure disorder
- No other severe and/or uncontrolled medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent immunomodulating agents
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy
Radiotherapy
- See Disease Characteristics
Prior palliative radiotherapy allowed
- No prior palliative radiotherapy to the chest except for ≤ 3 fractions for superior vena cava syndrome
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy
- More than 2 weeks since prior minor surgery* NOTE: *Insertion of a vascular access device is not considered major or minor surgery
Other
- More than 4 weeks since prior investigational therapy
- No concurrent Hypericum perforatum (St. John's wort)
- No concurrent inducers or inhibitors of CYP3A4
- No concurrent medications that are metabolized by CYP3A4
- No aspirin dose ≥ 1.3 grams per day for ≥ 10 days prior to and after study treatment
- No other concurrent cytostatic or cytotoxic agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: pemetrexed + carboplatin + radiation
Patients receive pemetrexed disodium IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease in the CNS only may receive whole-brain radiotherapy and then continue chemotherapy after completion of whole-brain radiotherapy for up to 6 courses. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of confirmed-tumor response
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Chee CE, Jett JR, Bernath AM Jr, Foster NR, Nelson GD, Molina J, Nikcevich DA, Steen PD, Flynn PJ, Rowland KM Jr. Phase 2 trial of pemetrexed disodium and carboplatin in previously untreated extensive-stage small cell lung cancer, N0423. Cancer. 2010 May 15;116(10):2382-9. doi: 10.1002/cncr.24967.
- Jett JR, Bernath AM, Foster NR, et al.: Phase II trial of pemetrexed (P) and carboplatin (C) in previously untreated extensive stage disease small cell lung cancer (ED-SCLC): A NCCTG Study. [Abstract] J Clin Oncol 26 (Suppl 15): A-8066, 2008.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Carboplatin
- Pemetrexed
Other Study ID Numbers
- NCCTG-N0423
- NCI-2012-02671 (REGISTRY: CTRP (Clinical Trials Reporting System))
- CDR0000442866 (REGISTRY: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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