Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT00077311

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 57 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

160

Study ID:

NCT00077311

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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