Lung Cancer Clinical Trial

S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in treating patients who have advanced non-small cell lung cancer.

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Full Description

OBJECTIVES:

Determine the survival of patients with advanced non-small cell lung cancer who are either age 70 and over or who have performance status 2, when treated with sequential vinorelbine and docetaxel. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)
Determine the objective tumor response rates, including confirmed and unconfirmed and complete and partial, in patients treated with this regimen.
Assess the dose delivered and the reported functional symptom status of patients treated with this regimen.
Determine the toxic effects of this regimen in these patients.
Determine the feasibility of performing pharmacokinetic studies and obtaining pharmacokinetic data on these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to age and performance status (age 70 and over with Zubrod 0-1 vs age 18 and over with Zubrod 2). (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)

Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Beginning 2 weeks after the last dose of vinorelbine, patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, at the beginning of courses 2-6, and at week 22.

Patients are followed at week 22, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A minimum of 95 patients (55 patients age 70 and over with Zubrod 0-1 and 40 patients age 18 and over with Zubrod 2) will be accrued for this study within 12-18 months. (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003.)

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed, newly diagnosed, advanced primary non-small cell lung cancer (NSCLC) (adenocarcinoma, large cell carcinoma, squamous cell carcinoma, or unspecified), designated as 1 of the following stages:

Selected stage IIIB (excluding Pancoast tumors)

T4 lesion due to malignant pleural effusion OR
Multiple lesions in a single lobe containing a T3 or T4 primary
Stage IV (any T, any N, M1)
Recurrent disease after prior surgery and/or radiotherapy
Measurable or evaluable disease outside of prior radiation port
No bronchoalveolar carcinoma
No brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-1 (for age 70 and over) (Age 70 and older with Zubrod 0-1 stratum closed to accrual as of 2/15/2003)
Zubrod 2 (for age 18 and over)

Life expectancy:

Not specified

Hematopoietic:

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than upper limit of normal (ULN)
SGOT/SGPT no greater than 2 times ULN if alkaline phosphatase is no greater than ULN OR
Alkaline phosphatase no greater than 4 times ULN if SGOT/SGPT are no greater than ULN

Renal:

Not specified

Other:

No prior severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
No grade 2 or greater sensory neuropathy
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior or concurrent biologic therapy for NSCLC
No concurrent filgrastim (G-CSF)

Chemotherapy:

No prior systemic chemotherapy for NSCLC

Endocrine therapy:

No prior or concurrent hormonal therapy for NSCLC

Radiotherapy:

See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered
Concurrent palliative radiotherapy to small-field nonmeasurable lesions (i.e., painful bony lesions) allowed
No other concurrent radiotherapy

Surgery:

See Disease Characteristics
At least 3 weeks since prior thoracic or other major surgery and recovered

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

125

Study ID:

NCT00026156

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 88 Locations for this study

See Locations Near You

MBCCOP - Gulf Coast
Mobile Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix Arizona, 85006, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona, 85723, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90033, United States
Veterans Affairs Medical Center - West Los Angeles
Los Angeles California, 90073, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California, 94553, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
David Grant Medical Center
Travis Air Force Base California, 94535, United States
University of Colorado Cancer Center
Denver Colorado, 80010, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia, 20060, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Tripler Army Medical Center
Honolulu Hawaii, 96859, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines Illinois, 60141, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Genesis Medical Center
Davenport Iowa, 52804, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky, 40502, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington Kentucky, 40536, United States
MBCCOP - LSU Medical Center
New Orleans Louisiana, 70112, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71130, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
St. Elizabeth's Medical Center
Boston Massachusetts, 02135, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain Massachusetts, 02130, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor Michigan, 48105, United States
CCOP - Ann Arbor Regional
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
CCOP - Beaumont
Royal Oak Michigan, 48073, United States
Providence Hospital - Southfield
Southfield Michigan, 48075, United States
Veterans Affairs Medical Center - Biloxi
Biloxi Mississippi, 39531, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi, 39216, United States
Keesler Medical Center - Keesler AFB
Keesler AFB Mississippi, 39534, United States
Veterans Affairs Medical Center - Kansas City
Kansas City Missouri, 64128, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
St. Louis University Health Sciences Center
Saint Louis Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico, 87108, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
Veterans Affairs Medical Center - Albany
Albany New York, 12208, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio, 45220, United States
Barrett Cancer Center
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City Oklahoma, 73104, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
CCOP - Columbia River Program
Portland Oregon, 97225, United States
Oregon Cancer Institute
Portland Oregon, 97239, United States
Veterans Affairs Medical Center - Charleston
Charleston South Carolina, 29401, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
University of Tennessee Cancer Institute
Memphis Tennessee, 38103, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Veterans Affairs Medical Center - Houston
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78229, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah, 84148, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

125

Study ID:

NCT00026156

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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