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A Phase II Trial of Concurrent Carboplatin/VP-16 and Radiation Followed by Paclitaxel (Taxol) for Poor-Risk Stage III Non-Small Cell Lung Cancer


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

Thank you

Trial Information

A Phase II Trial of Concurrent Carboplatin/VP-16 and Radiation Followed by Paclitaxel (Taxol) for Poor-Risk Stage III Non-Small Cell Lung Cancer


OBJECTIVES: I. Assess the survival and failure-free survival in poor risk patients with
stage IIIA or IIIB non-small cell lung carcinoma treated with concurrent radiation,
carboplatin, and etoposide followed by consolidation with paclitaxel. II. Evaluate the
response and toxicities associated with this regimen in this group of poor risk patients.

OUTLINE: This is nonrandomized study. Chemotherapy on cycle 1 starts on day 1 with
concurrent initiation of radiotherapy. Chemotherapy is given prior to radiotherapy on those
days when both treatments are given. Cycle 2 begins on day 29. Carboplatin is administered
by 15 minute IV infusions on days 1, 3, 29, and 31. Etoposide (VP-16) is administered after
carboplatin by 30 minute IV infusions on days 1-4, and 29-32. Radiation therapy begins
within 24 hours of day 1, cycle 1 of chemotherapy. The primary tumor, the adjacent
mediastinum, and other targeted lymph nodes are administered radiotherapy daily 5 days a
week for 6.5 weeks. After the 2 cycles of chemotherapy and chest radiotherapy, patients who
have stable disease, partial response, or complete response receive 3 cycles of paclitaxel.
Paclitaxel is administered by 3 hour IV infusions starting 4 weeks after completion of
chemotherapy and radiotherapy and repeated every 3-4 weeks (approximately days 71, 92, and
103) for a total of 3 cycles. Patients are followed every month for the first year, every 3
months for the second year, every 6 months for the third year, and then annually thereafter
while on treatment. After treatment, patients are followed every 6 months for 2 years and
then annually thereafter.

PROJECTED ACCRUAL: There will be 80 patients accrued in this study over 16 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed single primary
bronchogenic non-small cell lung cancer (NSCLC) Stage IIIA (T1-2 N2 M0; T3 N0-2 M0) or
IIIB (T4 or N3 M0, excluding malignant pleural effusion) Following NSCLC cellular types
are eligible: adenocarcinoma large cell carcinoma squamous cell carcinoma unspecified
Histology or cytology from involved mediastinal or supraclavicular nodes are sufficient
for diagnosis if a separate primary lesion of the lung parenchyma is clearly evident on
radiographs Radiographic evidence of mediastinal lymph nodes of at least 1.5 cm in the
largest diameter is sufficient to stage N2 or N3 If the largest mediastinal nodes are less
than 1.5 cm in diameter and this is the basis for stage III disease, then at least one of
the nodes has to be proven positive cytologically or histologically No bronchioloalveolar
carcinoma or stage IIIB tumor involving the superior sulcus Patients must meet at least
one of the following conditions: - FEV1 less than 2 liters and predicted FEV1 of the
contralateral lung no greater than 800 mL based on the quantitative split function testing
- Creatinine clearance less than 50 mL/min - Significant clinical hearing loss and
unwilling to accept the potential for worsening due to cisplatin - Controlled congestive
heart failure that, in the opinion of the investigator, may become decompensated due to
excessive hydration prior to cisplatin administration - SWOG performance status 2 and
either albumin less than 0.85 times upper limit of normal or weight loss of greater than
10% due to tumor Measurable or evaluable disease Patients with pleural effusion are
eligible only if: - pleural fluid must be a transudate with negative cytology if present
before mediastinoscopy or exploratory thoracotomy - pleural fluid can be either transudate
or exudate with negative cytology if present only after exploratory or staging thoracotomy
but not before - in any case, pleural effusion is present only on CT scan but not on
decubitus chest x-ray, and it is deemed too small to tap under either CT or ultrasound
guidance

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
1,200/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
upper limit of normal SGOT no greater than 1.5 times upper limit of normal Renal:
Creatinine clearance at least 20 mL/min Cardiovascular: No unstable congestive heart
failure No active angina No unstable cardiac arrhythmias Pulmonary: FEV1 at least 1.0
liter Also See Disease Characteristics Other: No uncontrolled peptic ulcer disease No
active infection No prior malignancy except adequately treated basal cell or squamous cell
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease free for 5 years Not pregnant or nursing Adequate contraception required of all
fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation for lung
cancer Surgery: No prior surgery for lung cancer

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Derick H. Lau, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000065951

NCT ID:

NCT00003158

Start Date:

February 1998

Completion Date:

December 2007

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • 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
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
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
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
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
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
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
Swedish Cancer InstituteSeattle, Washington  98104
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
University of California Davis Cancer CenterSacramento, California  95817
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Louisiana State University Hospital - ShreveportShreveport, Louisiana  71130-3932