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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077311

Purpose

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.

Condition	Intervention	Phase
Anemia Drug/Agent Toxicity by Tissue/Organ Lung Cancer Neutropenia	Biological: darbepoetin alfa Biological: pegfilgrastim Drug: cisplatin Drug: dimesna Drug: docetaxel	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Lung Cancer

Drug Information available for: Cisplatin Dimesna Docetaxel Pegfilgrastim Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence and severity of peripheral neuropathy
Feasibility
Objective response rate

Secondary Outcome Measures:

Survival and failure-free survival
Toxicity
Incidence and severity of cisplatin-induced nephrotoxicity

Study Start Date:	August 2006
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.

PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study within 18-20 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077311

Hide Study Locations

Locations

United States, California
El Camino Hospital
Mountain View, California, United States, 94040
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
St. Francis Hospital
Wilmington, Delaware, United States, 19805
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States, 61350
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States, 60612
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States, 21921
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
United States, Missouri
Arch Medical Services, Incorporated at Center for Cancer Care Research
Saint Louis, Missouri, United States, 63141
Missouri Baptist Cancer Center
St. Louis, Missouri, United States, 63131
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
Faxton Regional Cancer Center
Utica, New York, United States, 13502
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
United States, West Virginia
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States, 25702

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Antonius A. Miller, MD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Green MR, Miller AA, Wang XF, et al.: Phase II randomized study of dose-dense docetaxel (Doc) and cisplatin (Cis) every two weeks with pegfilgrastim (Pfil) and darbepoetin alfa (Darb) with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (NSCLC): CAL. [Abstract] J Clin Oncol 25 (Suppl 18): A-7617, 413s, 2007.

Study ID Numbers:	CDR0000350089, CALGB-30303
Study First Received:	February 10, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00077311 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Leukocyte Disorders
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Hematinics

Hematologic Diseases
Anemia
Agranulocytosis
Darbepoetin alfa
Pharmacologic Actions
Carcinoma
Neutropenia
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Leukopenia
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009