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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 Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
University of New Mexico Cancer Research & Treatment Center Albuquerque, New Mexico  87131
Swedish Hospital Tumor Institute Seattle, Washington  98104
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Louisiana State University Hospital - Shreveport Shreveport, Louisiana  71130-3932
CCOP - Ozarks Regional Springfield, Missouri  65807