Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00077311 | Completed Phase 2

• 3 other identifiers: CALGB-30303U10CA031946CDR0000350089
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 64

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy. 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.

Conditions

Anemia; Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Neutropenia

Keywords

drug/agent toxicity by tissue/organ; anemia; neutropenia; stage IV non-small cell lung cancer; stage IIIB non-small cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; adenosquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity

  Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity

  12 weeks

Secondary Outcomes (2)

• Response

  during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs

• Survival

  q 6 mon for 2 yrs after registration, then annually

Study Arms (2)

Chemotherapy without BNP7787

EXPERIMENTAL

Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC

Biological: darbepoetin alfa; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel

Chemotherapy + BNP7787

EXPERIMENTAL

Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787

Biological: darbepoetin alfa; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Drug: BNP7787

Interventions

darbepoetin alfa BIOLOGICAL

200 mcg sub Q on day 1 of each cycle if HgB \< or = 11 g/dL

Chemotherapy + BNP7787; Chemotherapy without BNP7787

pegfilgrastim BIOLOGICAL

6 mg sub Q day 2 of each cycle

Chemotherapy + BNP7787; Chemotherapy without BNP7787

cisplatin DRUG

75 mg/sq m IV over 1 hr Day 1 of each cycle

Chemotherapy + BNP7787; Chemotherapy without BNP7787

docetaxel DRUG

75 mg/sq m IV over 1 hr Day 1 of each cycle

Chemotherapy + BNP7787; Chemotherapy without BNP7787

BNP7787 DRUG

40 g IV over 30 min Day 1 of each cycle

Chemotherapy + BNP7787

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (64)

El Camino Hospital

Mountain View, California, 94040, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

St. Francis Hospital

Wilmington, Delaware, 19805, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

Veterans Affairs Medical Center - Chicago Westside Hospital

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Oncology Hematology Associates of Central Illinois - Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, 21201, United States

Location

Union Hospital Cancer Center at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Arch Medical Services, Incorporated at Center for Cancer Care Research

St Louis, Missouri, 63141, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

Methodist Cancer Center at Methodist Hospital - Omaha

Omaha, Nebraska, 68114, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131-2197, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

New Hampshire Oncology-Hematology, PA - Hooksett

Hooksett, New Hampshire, 03106, United States

Location

Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States

Location

Elliot Regional Cancer Center

Manchester, New Hampshire, 03103, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

CCOP - Hematology-Oncology Associates of Central New York

Syracuse, New York, 13057, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Community General Hospital of Greater Syracuse

Syracuse, New York, 13215, United States

Location

Faxton Regional Cancer Center

Utica, New York, 13502, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Lenoir Memorial Cancer Center

Kinston, North Carolina, 28501, United States

Location

Zimmer Cancer Center at New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Cancer Care Associates - Mercy Campus

Oklahoma City, Oklahoma, 73120, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, United States

Location

Veterans Affairs Medical Center - Dallas

Dallas, Texas, 75216, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

Zale Lipshy University Hospital

Dallas, Texas, 75235, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

St. Mary's Regional Cancer Center at St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Related Publications (1)

• 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.

  PMID: 18827613 RESULT

MeSH Terms

Conditions

Anemia; Drug-Related Side Effects and Adverse Reactions; Lung Neoplasms; Neutropenia; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Darbepoetin alfa; pegfilgrastim; Cisplatin; Docetaxel; 2,2'-dithiodiethanesulfonic acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Chemically-Induced Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Antonius Miller, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: August 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: April 1, 2009
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

US (64)