A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer
N/A
N/A
Both
Lung Cancer
Trial Information
A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer
OBJECTIVES:
- Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when
administered concurrently with paclitaxel and carboplatin in patients with inoperable
stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of
01/13/04.)
- Determine the 12-month survival rate in patients treated with this regimen. (Phase II)
(Closed to accrual as of 11/27/07.)
- Determine the toxicity of this regimen in these patients.
- Determine the partial organ tolerance doses for the lung and esophagus in patients
treated with this regimen.
- Determine the complete response rate in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal
radiotherapy.
- Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal
radiotherapy once daily five days a week for 7-8 weeks. Patients also receive
concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV
over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.
Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy
until the maximum tolerated dose (MTD) is determined when given in combination with
chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients
experience dose-limiting toxicity.
- Phase II: Additional patients are accrued and treated as above at the MTD. At least 3
weeks after completing radiotherapy, patients may receive additional chemotherapy
comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once.
Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I [closed to accrual as of
10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed unresectable stage IIIA or IIIB non-small
cell lung cancer
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Non-small cell carcinoma not otherwise specified
- All detectable primary tumor and involved regional lymph nodes must be encompassed by
radiotherapy fields
- Measurable disease on 3-dimensional planning CT scan
- No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma
- No stage IV or recurrent disease
- No distant metastases or supraclavicular lymph node involvement
- No significant atelectasis (i.e., atelectasis of an entire lung)
- No pleural effusions, pericardial effusions, or superior vena cava syndrome
- No lung cancer within the past 2 years
- Ineligible for currently open RTOG phase III lung protocols
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Pulmonary:
- FEV_1 at least 1.0 L
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss greater than 5% in the past 6 months
- No other malignancy within the past year except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic response modifiers for current lung cancer
- At least 5 years since prior biologic response modifiers
Chemotherapy:
- No prior chemotherapy for current lung cancer
- At least 5 years since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to the thorax
Surgery:
- No prior complete tumor resection
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Safety Issue:
Yes
Principal Investigator
Jeffrey Bradley, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mallinckrodt Institute of Radiology at Washington University Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000068850
NCT ID:
NCT00023673
Start Date:
July 2001
Completion Date:
Related Keywords:
- Lung Cancer
- squamous cell lung cancer
- large cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- adenocarcinoma of the lung
- adenosquamous cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
| Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
| David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
| Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
| Providence Holy Cross Cancer Center | Mission Hills, California 91346-9600 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
| Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
| Three Rivers Community Hospital | Grants Pass, Oregon 97527 |
| Dubs Cancer Center at Rogue Valley Medical Center | Medford, Oregon 97504 |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
| Alexian Brothers Radiation Oncology | Elk Grove Village, Illinois 60007 |
| Bay Medical | Panama City, Florida 32401 |
| Oncology Center at Saint Margaret Mercy Healthcare Center | Hammond, Indiana 46320 |
| Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
| Ocean Medical Center at Meridian Health | Brick, New Jersey 08724 |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
| High Point Regional Hospital | High Point, North Carolina 27261 |
| Providence Cancer Center at PMCC | Medford, Oregon 97504 |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
