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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 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
Chao Family Comprehensive Cancer Center Orange, California  92868
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
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
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
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 - Cancer Research for the Ozarks Springfield, Missouri  65807
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
Swedish Cancer Institute Seattle, Washington  98104
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
University of California Davis Cancer Center Sacramento, California  95817
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Louisiana State University Hospital - Shreveport Shreveport, Louisiana  71130-3932