--- title: Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer nct_id: NCT00227565 overall_status: COMPLETED phase: PHASE2 sponsor: Alliance for Clinical Trials in Oncology study_type: INTERVENTIONAL primary_condition: Lung Cancer countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00227565.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00227565" ct_last_update_post_date: 2016-07-06 last_seen_at: "2026-05-12T07:18:00.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Pemetrexed Disodium and Carboplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer **Official Title:** Phase II Trial of Pemetrexed Disodium and Carboplatin in Previously Untreated Extensive Stage Small Cell Lung Cancer **NCT ID:** [NCT00227565](https://clinicaltrials.gov/study/NCT00227565) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 50 - **Lead Sponsor:** Alliance for Clinical Trials in Oncology - **Collaborators:** National Cancer Institute (NCI) - **Conditions:** Lung Cancer - **Start Date:** 2006-02 - **Completion Date:** 2009-10 - **CT.gov Last Update:** 2016-07-06 ## Brief 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. ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **pemetrexed + carboplatin + radiation** (EXPERIMENTAL) — 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. ## Interventions - **carboplatin** (DRUG) - **pemetrexed disodium** (DRUG) - **radiation** (RADIATION) ## Primary Outcomes - **Proportion of confirmed-tumor response** _(time frame: Up to 5 years)_ ## Locations (148) - Mayo Clinic Scottsdale, Scottsdale, Arizona, United States - Aurora Presbyterian Hospital, Aurora, Colorado, United States - Boulder Community Hospital, Boulder, Colorado, United States - Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States - St. Anthony Central Hospital, Denver, Colorado, United States - Porter Adventist Hospital, Denver, Colorado, United States - Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States - St. Joseph Hospital, Denver, Colorado, United States - Rose Medical Center, Denver, Colorado, United States - CCOP - Colorado Cancer Research Program, Denver, Colorado, United States - Swedish Medical Center, Englewood, Colorado, United States - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States - North Colorado Medical Center, Greeley, Colorado, United States - Sky Ridge Medical Center, Lone Tree, Colorado, United States - Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States - McKee Medical Center, Loveland, Colorado, United States - St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States - North Suburban Medical Center, Thornton, Colorado, United States - Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States - Mayo Clinic - Jacksonville, Jacksonville, Florida, United States - Rush-Copley Cancer Care Center, Aurora, Illinois, United States - St. Joseph Medical Center, Bloomington, Illinois, United States - Graham Hospital, Canton, Illinois, United States - Memorial Hospital, Carthage, Illinois, United States - Eureka Community Hospital, Eureka, Illinois, United States - Galesburg Clinic, PC, Galesburg, Illinois, United States - Galesburg Cottage Hospital, Galesburg, Illinois, United States - Mason District Hospital, Havana, Illinois, United States - Hopedale Medical Complex, Hopedale, Illinois, United States - Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States - Kewanee Hospital, Kewanee, Illinois, United States - McDonough District Hospital, Macomb, Illinois, United States - BroMenn Regional Medical Center, Normal, Illinois, United States - Community Cancer Center, Normal, Illinois, United States - Community Hospital of Ottawa, Ottawa, Illinois, United States - Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa, Illinois, United States - Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States - Proctor Hospital, Peoria, Illinois, United States - CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States - Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States - Methodist Medical Center of Illinois, Peoria, Illinois, United States - OSF St. Francis Medical Center, Peoria, Illinois, United States - Illinois Valley Community Hospital, Peru, Illinois, United States - Perry Memorial Hospital, Princeton, Illinois, United States - St. Margaret's Hospital, Spring Valley, Illinois, United States - Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States - CCOP - Carle Cancer Center, Urbana, Illinois, United States - St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States - Elkhart General Hospital, Elkhart, Indiana, United States - Howard Community Hospital, Kokomo, Indiana, United States - Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States - Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States - Reid Hospital & Health Care Services, Richmond, Indiana, United States - CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States - Memorial Hospital of South Bend, South Bend, Indiana, United States - Saint Joseph Regional Medical Center, South Bend, Indiana, United States - McFarland Clinic, PC, Ames, Iowa, United States - Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States - Mercy Capitol Hospital, Des Moines, Iowa, United States - CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States - John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States - Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States - Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States - Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States - John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States - Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, United States - Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States - Mercy Medical Center - Sioux City, Sioux City, Iowa, United States - St. Luke's Regional Medical Center, Sioux City, Iowa, United States - Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States - CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States - Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States - Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States - Genesys Hurley Cancer Institute, Flint, Michigan, United States - Hurley Medical Center, Flint, Michigan, United States - Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States - Dickinson County Healthcare System, Iron Mountain, Michigan, United States - Foote Memorial Hospital, Jackson, Michigan, United States - Sparrow Regional Cancer Center, Lansing, Michigan, United States - St. Mary Mercy Hospital, Livonia, Michigan, United States - St. Joseph Mercy Oakland, Pontiac, Michigan, United States - Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States - Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States - Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States - St. John Macomb Hospital, Warren, Michigan, United States - Albert Lea Cancer Center at Albert Lea Medical Center, Albert Lea, Minnesota, United States - MeritCare Bemidji, Bemidji, Minnesota, United States - Fairview Ridges Hospital, Burnsville, Minnesota, United States - Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States - Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States - CCOP - Duluth, Duluth, Minnesota, United States - Miller - Dwan Medical Center, Duluth, Minnesota, United States - Fairview Southdale Hospital, Edina, Minnesota, United States - Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States - Hutchinson Area Health Care, Hutchinson, Minnesota, United States - Meeker County Memorial Hospital, Lichfield, Minnesota, United States - HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States - Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States - Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States - Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States - Mayo Clinic Cancer Center, Rochester, Minnesota, United States - CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States - Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States - Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States - HealthEast Cancer Care at St. Joseph's Hospital, Saint Paul, Minnesota, United States - United Hospital, Saint Paul, Minnesota, United States - St. Francis Cancer Center at St. Francis Medical Center, Shakopee, Minnesota, United States - Ridgeview Medical Center, Waconia, Minnesota, United States - HealthEast Cancer Care at Woodwinds Health Campus, Woodbury, Minnesota, United States - Minnesota Oncology Hematology, PA - Woodbury, Woodbury, Minnesota, United States - Rutherford Hospital, Rutherfordton, North Carolina, United States - Bismarck Cancer Center, Bismarck, North Dakota, United States - Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, United States - Mid Dakota Clinic, PC, Bismarck, North Dakota, United States - St. Alexius Medical Center Cancer Center, Bismarck, North Dakota, United States - CCOP - MeritCare Hospital, Fargo, North Dakota, United States - MeritCare Broadway, Fargo, North Dakota, United States - Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota, United States - Grandview Hospital, Dayton, Ohio, United States - Good Samaritan Hospital, Dayton, Ohio, United States - David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States - Samaritan North Cancer Care Center, Dayton, Ohio, United States - Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States - CCOP - Dayton, Dayton, Ohio, United States - Blanchard Valley Medical Associates, Findlay, Ohio, United States - Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States - Middletown Regional Hospital, Middletown, Ohio, United States - UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States - Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States - Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States - Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States - Geisinger Medical Group - Scenery Park, State College, Pennsylvania, United States - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States - AnMed Cancer Center, Anderson, South Carolina, United States - CCOP - Upstate Carolina, Spartanburg, South Carolina, United States - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States - Avera Cancer Institute, Sioux Falls, South Dakota, United States - Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States - Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States - Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States - St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States - St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States - Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States - Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States - Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.mayo clinic scottsdale|scottsdale|arizona|united states` — added _(2026-05-12)_ - `locations.aurora presbyterian hospital|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.boulder community hospital|boulder|colorado|united states` — added _(2026-05-12)_ - `locations.penrose cancer center at penrose hospital|colorado springs|colorado|united states` — added _(2026-05-12)_ - `locations.st. anthony central hospital|denver|colorado|united states` — added _(2026-05-12)_ - `locations.porter adventist hospital|denver|colorado|united states` — added _(2026-05-12)_ - `locations.presbyterian - st. luke's medical center|denver|colorado|united states` — added _(2026-05-12)_ - `locations.st. joseph hospital|denver|colorado|united states` — added _(2026-05-12)_ - `locations.rose medical center|denver|colorado|united states` — added _(2026-05-12)_ - `locations.ccop - colorado cancer research program|denver|colorado|united states` — added _(2026-05-12)_ - `locations.swedish medical center|englewood|colorado|united states` — added _(2026-05-12)_ - `locations.st. mary's regional cancer center at st. mary's hospital and medical center|grand junction|colorado|united states` — added _(2026-05-12)_ - `locations.north colorado medical center|greeley|colorado|united states` — added _(2026-05-12)_ - `locations.sky ridge medical center|lone tree|colorado|united states` — added _(2026-05-12)_ - `locations.hope cancer care center at longmont united hospital|longmont|colorado|united states` — added _(2026-05-12)_ - `locations.mckee medical center|loveland|colorado|united states` — added _(2026-05-12)_ - `locations.st. mary - corwin regional medical center|pueblo|colorado|united states` — added _(2026-05-12)_ - `locations.north suburban medical center|thornton|colorado|united states` — added _(2026-05-12)_ - `locations.exempla lutheran medical center|wheat ridge|colorado|united states` — added _(2026-05-12)_ - `locations.mayo clinic - jacksonville|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.rush-copley cancer care center|aurora|illinois|united states` — added _(2026-05-12)_ - `locations.st. joseph medical center|bloomington|illinois|united states` — added _(2026-05-12)_ - `locations.graham hospital|canton|illinois|united states` — added _(2026-05-12)_ - `locations.memorial hospital|carthage|illinois|united states` — added _(2026-05-12)_ - `locations.eureka community hospital|eureka|illinois|united states` — added _(2026-05-12)_ - `locations.galesburg clinic, pc|galesburg|illinois|united states` — added _(2026-05-12)_ - `locations.galesburg cottage hospital|galesburg|illinois|united states` — added _(2026-05-12)_ - `locations.mason district hospital|havana|illinois|united states` — added _(2026-05-12)_ - `locations.hopedale medical complex|hopedale|illinois|united states` — added _(2026-05-12)_ - `locations.joliet oncology-hematology associates, limited - west|joliet|illinois|united states` — added _(2026-05-12)_ - `locations.kewanee hospital|kewanee|illinois|united states` — added _(2026-05-12)_ - `locations.mcdonough district hospital|macomb|illinois|united states` — added _(2026-05-12)_ - `locations.bromenn regional medical center|normal|illinois|united states` — added _(2026-05-12)_ - `locations.community cancer center|normal|illinois|united states` — added _(2026-05-12)_ - `locations.community hospital of ottawa|ottawa|illinois|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00227565.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00227565* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*