Phase II Trial of Paclitaxel by 96-Hour Infusion in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer
Both
Lung Cancer
Trial Information
Phase II Trial of Paclitaxel by 96-Hour Infusion in Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
OBJECTIVES: I. Assess survival, progression-free survival and response rate of patients with
bronchioloalveolar carcinoma receiving paclitaxel. II. Evaluate toxic effects of paclitaxel
in 96 hour continuous infusion patients.
OUTLINE: Patients receive 6 cycles of paclitaxel by IV continuous infusion over 96 hours.
Before cycle 4, restaging is performed. If disease progression is witnessed, patients are
removed from the study. If a stable, partial, or complete response is observed, patients
receive the total of 6 cycles. Three weeks after the last cycle, final restaging is
performed. Patients are followed every 3 months while on treatment and every 6 months
thereafter, unless more frequent follow-up is clinically recommended.
PROJECTED ACCRUAL: 50 patients will be enrolled. The accrual rate is estimated at 25 per
year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven Stage IIIB or IV bronchioloalveolar
non-small cell lung carcinoma -incompletely resected or unresectable -tumors may be
multifocal or diffuse -measurable or evaluable disease required No prior brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: SWOG 0-2 Life Expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than institutional upper limit of
normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than
institutional ULN OR creatinine clearance at least 50 mL/min Other: Not pregnant or
nursing Effective contraceptive method used while on study No prior malignancies allowed,
except: basal or squamous cell skin cancer in situ cervical cancer Stage I or II cancer
which is in remission Any cancer from which patients have been disease free for 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for lung cancer
Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No
prior radiation therapy (including palliative radiotherapy) Surgery: Prior surgery is
allowed
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Ralph B. Vance, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Mississippi Cancer Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000065476
NCT ID:
NCT00002969
Start Date:
May 1997
Completion Date:
January 2007
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Adenocarcinoma, Bronchiolo-Alveolar
- 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 |
| 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 |
| 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 |
