A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
- Determine the maximum tolerated dose (MTD) of gemcitabine when administered with
carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin
in patients with stage IIIA or IIIB non-small cell lung cancer.
- Determine the MTD of gemcitabine and paclitaxel when administered with thoracic
radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients.
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel.
Patients are sequentially assigned to 1 of 3 treatment regimens.
- Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and
43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1.
- Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic
radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29,
- Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and
paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43.
At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine
IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days
71 and 92.
The first 6 patients enrolled receive regimen A to determine the safety of the initial dose
of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating
doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum
tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive
alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is
determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients
experience dose-limiting toxicity.
Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2
years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.
Primary Purpose: Treatment
Hak Choy, MD
Simmons Cancer Center
United States: Federal Government
|Akron City Hospital||Akron, Ohio 44304|
|Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center||La Crosse, Wisconsin 54601|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|CCOP - Bay Area Tumor Institute||Oakland, California 94609-3305|
|Wendt Regional Cancer Center of Finley Hospital||Dubuque, Iowa 52001|
|Delaware County Memorial Hospital||Drexel Hill, Pennsylvania 19026|
|Mercy Hospital of Pittsburgh||Pittsburgh, Pennsylvania 15219|
|Dixie Regional Medical Center||Saint George, Utah 84770|
|LDS Hospital||Salt Lake City, Utah 84143|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)||Milwaukee, Wisconsin 53295|
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|
|Utah Valley Regional Medical Center - Provo||Provo, Utah 84604|
|Monmouth Medical Center||Long Branch, New Jersey 07740-6395|
|Cottonwood Hospital Medical Center||Murray, Utah 84107|
|McKay-Dee Hospital Center||Ogden, Utah 84403|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Dale and Frances Hughes Cancer Center||East Stroudsburg, Pennsylvania 18301|
|Cancer Care Center, Incorporated||Salem, Ohio 44460|