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.

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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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT00227565

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 122 Locations for this study

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Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
St. Anthony Central Hospital
Denver Colorado, 80204, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction Colorado, 81502, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80502, United States
McKee Medical Center
Loveland Colorado, 80539, United States
St. Mary - Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge Colorado, 80033, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
St. Joseph Medical Center
Bloomington Illinois, 61701, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria Illinois, 61637, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Reid Hospital & Health Care Services
Richmond Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Saint Joseph Regional Medical Center
South Bend Indiana, 46617, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City Iowa, 50401, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Green Bay Oncology, Limited - Escanaba
Escanaba Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain Michigan, 49801, United States
Foote Memorial Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
St. Mary Mercy Hospital
Livonia Michigan, 48154, United States
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph Michigan, 49085, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
Albert Lea Cancer Center at Albert Lea Medical Center
Albert Lea Minnesota, 56007, United States
MeritCare Bemidji
Bemidji Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth Minnesota, 55805, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth Minnesota, 55805, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Meeker County Memorial Hospital
Lichfield Minnesota, 55355, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood Minnesota, 55109, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis Minnesota, 55415, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee Minnesota, 55379, United States
HealthEast Cancer Care at St. Joseph's Hospital
St Paul Minnesota, 55102, United States
Park Nicollet Cancer Center
St. Louis Park Minnesota, 55416, United States
Regions Hospital Cancer Care Center
St. Paul Minnesota, 55101, United States
United Hospital
St. Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury Minnesota, 55125, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury Minnesota, 55125, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck North Dakota, 58502, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Broadway
Fargo North Dakota, 58122, United States
Altru Cancer Center at Altru Hospital
Grand Forks North Dakota, 58201, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown Pennsylvania, 18105, United States
Geisinger Cancer Institute at Geisinger Health
Danville Pennsylvania, 17822, United States
Geisinger Medical Group - Scenery Park
State College Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls Wisconsin, 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay Wisconsin, 54235, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT00227565

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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