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.
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.)
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
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There are 88 Locations for this study
Mobile Alabama, 36688, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85012, United States
Tucson Arizona, 85723, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Los Angeles California, 90073, United States
Los Angeles California, 90095, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Denver Colorado, 80010, United States
Denver Colorado, 80220, United States
Washington District of Columbia, 20060, United States
Atlanta Georgia, 30342, United States
Fort Gordon Georgia, 30905, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96859, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62526, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Davenport Iowa, 52804, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67218, United States
Lexington Kentucky, 40502, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71130, United States
Shreveport Louisiana, 71130, United States
Boston Massachusetts, 02118, United States
Boston Massachusetts, 02135, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48105, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Royal Oak Michigan, 48073, United States
Southfield Michigan, 48075, United States
Biloxi Mississippi, 39531, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Keesler AFB Mississippi, 39534, United States
Kansas City Missouri, 64128, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
Albany New York, 12208, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27104, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97207, United States
Portland Oregon, 97225, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Memphis Tennessee, 38103, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Temple Texas, 76504, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84148, United States
Seattle Washington, 98101, United States
Seattle Washington, 98108, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98431, United States
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