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Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer


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

Thank you

Trial Information

Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer


OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced
primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by
paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response
(confirmed plus unconfirmed) and toxicities associated with these two regimens in these
patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV
over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following
the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on
day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes
on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats
every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients
receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no
further treatment until evidence of disease progression. Patients are followed every 2
months for the first year, every 6 months for years 2 and 3, and annually thereafter.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed stage IIIB or IV
advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma,
squamous cell carcinoma, or unspecified) or recurrent non-small cell lung cancer after
previous surgery and/or radiotherapy Stage IIIB: T4 lesion due to malignant pleural
effusion, OR multiple lesions in a single lobe containing a T3 or T4 primary, OR lesions
in multiple lobes of the ipsilateral lung for which one such lesion is T3 or T4 Any N M0
Stage IV: Any T, Any N, M1 Measurable or evaluable disease Measurable or evaluable disease
must be outside of the prior radiotherapy port or prior surgical resection area No brain
metastases No bronchoalveolar carcinoma or stage IIIB tumor involving the superior sulcus
(pancoast tumors)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no
greater than 2 times upper limit of normal AND Creatinine clearance at least 50 mL/min
Other: No prior malignancy in the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I
or II cancer from which the patient is currently in complete remission Not pregnant or
nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for non-small cell
lung cancer No concurrent biologic therapy to measurable or evaluable lesions
Chemotherapy: No prior systemic chemotherapy for non-small cell lung cancer Endocrine
therapy: No concurrent hormonal therapy to measurable or evaluable lesions Radiotherapy:
At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy to
measurable lesions Palliative radiation to small field nonmeasurable sites of disease
(painful bony metastases) allowed Surgery: At least 3 weeks since surgery (thoracic or
other major surgeries) and recovered

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Martin J. Edelman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Veterans Affairs Medical Center - Baltimore

Authority:

United States: Federal Government

Study ID:

CDR0000066656

NCT ID:

NCT00003587

Start Date:

October 1998

Completion Date:

January 2007

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
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
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
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
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 - Montana Cancer ConsortiumBillings, Montana  59101
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
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
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 - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
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
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
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
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
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Swedish Hospital Tumor InstituteSeattle, Washington  98104
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Louisiana State University Hospital - ShreveportShreveport, Louisiana  71130-3932
CCOP - Ozarks RegionalSpringfield, Missouri  65807