Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
NCT ID: NCT00006012
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
73 participants
INTERVENTIONAL
2001-02-28
2006-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before, during, and after radiation therapy in treating patients who have limited-stage small cell lung cancer.
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Detailed Description
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* Determine the maximum tolerated dose of thoracic radiotherapy administered with cisplatin, etoposide, and amifostine preceded and followed by topotecan and paclitaxel in patients with limited stage small cell lung cancer (phase I closed to accrual as of 5/27/2004).
* Determine the two-year survival of this patient population treated with this regimen.
* Determine the two-year, progression-free local control rate in this patient population treated with this regimen.
* Assess the tolerability of this treatment regimen in these patients.
* Determine the antitumor activity of this regimen in these patients.
* Determine the overall survival and overall time to progression in this patient population treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of thoracic radiotherapy (TRT).
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses.
After 2 courses of topotecan and paclitaxel, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT.
At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation.
Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity (phase I closed to accrual as of 5/27/2004).
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 3-73 patients will be accrued for this study (phase I closed to accrual as of 5/27/2004).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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topotecan + paclitaxel + filgrastim + TRT + radiation
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 2 courses.
After 2 courses of treatment, patients undergo TRT twice daily for 5 consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and amifostine SC daily prior to TRT.
At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan, paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
filgrastim
amifostine trihydrate
cisplatin
etoposide
paclitaxel
topotecan hydrochloride
radiation therapy
Interventions
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filgrastim
amifostine trihydrate
cisplatin
etoposide
paclitaxel
topotecan hydrochloride
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed small cell lung cancer
* Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa, and encompassable within tolerable thoracic radiotherapy field
* Minimal pleural effusions (i.e., blunting of the costophrenic angle on chest x-ray or a small effusion on CT scan) allowed
* Measurable disease
* At least one lesion accurately measured in at least 1 dimension with longest diameter at least 20 mm
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Pulmonary:
* FEV\_1 at least 40% of predicted AND at least 1 liter
Other:
* No uncontrolled infection
* No other severe underlying diseases
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas (carcinoma in situ)
* No grade 2 or greater peripheral neuropathy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to E.coli-derived proteins, filgrastim (G-CSF), or any excipients of G-CSF
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* No prior hemithorax radiotherapy
Surgery
* Not specified
Other
* No prior therapy for small cell lung cancer
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Scott Okuno, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, 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
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
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 - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
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
Valley Cancer Center
Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
McFarland Clinic, P.C.
Ames, Iowa, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Siouxland Hematology-Oncology Associates
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
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates in Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Bryan LGH Medical Center West
Lincoln, Nebraska, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
MeritCare Medical Group
Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Medical X-Ray Center
Sioux Falls, South Dakota, United States
Franciscan Skemp Healthcare
La Crosse, Wisconsin, United States
Countries
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References
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Garces YI, Okuno SH, Schild SE, Mandrekar SJ, Bot BM, Martens JM, Wender DB, Soori GS, Moore DF Jr, Kozelsky TF, Jett JR. Phase I North Central Cancer Treatment Group Trial-N9923 of escalating doses of twice-daily thoracic radiation therapy with amifostine and with alternating chemotherapy in limited stage small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):995-1001. doi: 10.1016/j.ijrobp.2006.10.034.
Garces YI, Okuno SH, Schild SE, et al.: A phase I/II NCCTG trial of escalating doses of twice daily thoracic radiation therapy (TRT) in limited-stage small cell lung cancer (LSCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7163, 661s, 2005.
Other Identifiers
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CDR0000068021
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N9923
Identifier Type: -
Identifier Source: org_study_id
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