Lung Cancer Clinical Trial
Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Summary
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.
Full 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.
Eligibility Criteria
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
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There are 122 Locations for this study
Scottsdale Arizona, 85259, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80204, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80224, United States
Englewood Colorado, 80110, United States
Grand Junction Colorado, 81502, United States
Greeley Colorado, 80631, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80502, United States
Loveland Colorado, 80539, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Wheat Ridge Colorado, 80033, United States
Jacksonville Florida, 32224, United States
Aurora Illinois, 60507, United States
Bloomington Illinois, 61701, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Beech Grove Indiana, 46107, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Michigan City Indiana, 46360, United States
Richmond Indiana, 47374, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Ames Iowa, 50010, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Mason City Iowa, 50401, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
St. Joseph Michigan, 49085, United States
Warren Michigan, 48093, United States
Albert Lea Minnesota, 56007, United States
Bemidji Minnesota, 56601, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Lichfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Shakopee Minnesota, 55379, United States
St Paul Minnesota, 55102, United States
St. Louis Park Minnesota, 55416, United States
St. Paul Minnesota, 55101, United States
St. Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Woodbury Minnesota, 55125, United States
Rutherfordton North Carolina, 28139, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Grand Forks North Dakota, 58201, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Findlay Ohio, 45840, United States
Kettering Ohio, 45429, United States
Middletown Ohio, 45044, United States
Troy Ohio, 45373, United States
Xenia Ohio, 45385, United States
Tulsa Oklahoma, 74136, United States
Allentown Pennsylvania, 18105, United States
Danville Pennsylvania, 17822, United States
State College Pennsylvania, 16801, United States
Wilkes-Barre Pennsylvania, 18711, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Marinette Wisconsin, 54143, United States
Oconto Falls Wisconsin, 54154, United States
Sturgeon Bay Wisconsin, 54235, United States
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