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Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2


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.)

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Paul J. Hesketh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Steward St. Elizabeth's Medical Center of Boston, Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000068991

NCT ID:

NCT00026156

Start Date:

November 2001

Completion Date:

November 2008

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Rochester Medical CenterRochester, New York  14642
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
University of California Davis Cancer CenterSacramento, California  95817
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Oregon Cancer InstitutePortland, Oregon  97201-3098
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Barrett Cancer CenterCincinnati, Ohio  45267-0502
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Genesis Medical CenterDavenport, Iowa  52804
St. Elizabeth's Medical CenterBoston, Massachusetts  02135-2997