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)
N/A
N/A
Both
Lung Cancer
Trial Information
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)
OBJECTIVES:
- 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,
and 43.
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed loco-regionally advanced non-small cell
lung cancer meeting one of the following staging criteria:
- Medically inoperable stage IIIA
- Unresectable stage IIIA or IIIB
- Measurable disease on three-dimensional planning CT scan
- No post-resection intrathoracic tumor recurrence
- No pleural effusion on chest x-ray except those occurring after attempted thoracotomy
or other invasive thoracic procedure
- No evidence of small cell histology
- No evidence of hematogenous or distant metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Absolute granulocyte count at least 2,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 1.5 times upper limit of normal (unless caused by documented
benign disease)
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- No symptomatic heart disease, including angina, congestive heart failure, or
uncontrolled arrhythmia
Pulmonary:
- FEV_1 greater than 1,000 mL
Other:
- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
- No weight loss of more than 10% in 3 months prior to diagnosis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior thoracic or neck radiotherapy
Surgery:
- See Disease Characteristics
- No prior complete or subtotal tumor resection
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Hak Choy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Simmons Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068622
NCT ID:
NCT00016315
Start Date:
May 2001
Completion Date:
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 |
|---|---|
| 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 |
