Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT ID: NCT00077311
Last Updated: 2016-06-30
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
PHASE2
160 participants
INTERVENTIONAL
2004-08-31
2009-04-30
Brief Summary
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PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
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Detailed Description
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Primary
* Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna.
* Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients.
* Compare the objective response rate in patients treated with these regimens.
Secondary
* Compare the survival and failure-free survival of patients treated with these regimens.
* Compare the toxicity profile of these regimens in these patients.
* Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I\*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2.
* Arm II\*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1.
NOTE: \*In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL.
In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy without BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB \< or = 11 g/dL
pegfilgrastim
6 mg sub Q day 2 of each cycle
cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB \< or = 11 g/dL
pegfilgrastim
6 mg sub Q day 2 of each cycle
cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
BNP7787
40 g IV over 30 min Day 1 of each cycle
Interventions
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darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB \< or = 11 g/dL
pegfilgrastim
6 mg sub Q day 2 of each cycle
cisplatin
75 mg/sq m IV over 1 hr Day 1 of each cycle
docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
BNP7787
40 g IV over 30 min Day 1 of each cycle
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed\* non-small cell lung cancer of 1 of the following subtypes:
* Squamous carcinoma
* Basaloid carcinoma
* Adenocarcinoma
* Bronchoalveolar carcinoma
* Adenosquamous carcinoma
* Large cell carcinoma
* Large cell neuroendocrine carcinoma
* Giant cell carcinoma
* Sarcomatoid carcinoma
* Non-small cell carcinoma not otherwise specified NOTE: \*Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection
* Stage IIIB disease due to malignant pleural effusion OR stage IV disease
* Measurable disease
* At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* The following are considered nonmeasurable disease:
* Bone lesions
* Brain metastases or leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* Tumor lesions situated in a previously irradiated area
* Brain metastases are allowed provided patient is neurologically stable and off steroids
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* AST ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ ULN
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No grade 2 or greater neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No other concurrent growth factors
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
Radiotherapy
* See Disease Characteristics
* Prior radiotherapy allowed for brain metastases only
* No concurrent palliative radiotherapy
Surgery
* See Disease Characteristics
18 Years
120 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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Antonius Miller, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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El Camino Hospital
Mountain View, California, United States
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
St. Francis Hospital
Wilmington, Delaware, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic
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
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
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
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
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Arch Medical Services, Incorporated at Center for Cancer Care Research
St Louis, Missouri, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees Township, New Jersey, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Community General Hospital of Greater Syracuse
Syracuse, New York, United States
Faxton Regional Cancer Center
Utica, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
Zale Lipshy University Hospital
Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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References
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Miller AA, Wang XF, Gu L, Hoffman P, Khatri J, Dunphy F, Edelman MJ, Bolger M, Vokes EE, Green MR; Cancer and Leukemia Group B (CALGB). Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303). J Thorac Oncol. 2008 Oct;3(10):1159-65. doi: 10.1097/JTO.0b013e318186fb0d.
Other Identifiers
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CALGB-30303
Identifier Type: -
Identifier Source: secondary_id
CDR0000350089
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-30303
Identifier Type: -
Identifier Source: org_study_id
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