Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00023673

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]
Percentage of patients who survive at least 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Partial organ tolerance doses for lung and esophagus [ Designated as safety issue: Yes ]
Complete response rate at 3 months after therapy [ Designated as safety issue: No ]

Estimated Enrollment:	73
Study Start Date:	July 2001
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023673

Hide Study Locations

Locations

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
United States, California
Providence Holy Cross Cancer Center
Mission Hills, California, United States, 91346-9600
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Florida
Bay Medical
Panama City, Florida, United States, 32401
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Illinois
Alexian Brothers Radiation Oncology
Elk Grove Village, Illinois, United States, 60007
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
United States, Indiana
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Oncology Center at Saint Margaret Mercy Healthcare Center
Hammond, Indiana, United States, 46320
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
United States, New Jersey
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States, 08360
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Ocean Medical Center at Meridian Health
Brick, New Jersey, United States, 08724
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
United States, North Carolina
High Point Regional Hospital
High Point, North Carolina, United States, 27261
United States, Ohio
Cancer Treatment Center
Wooster, Ohio, United States, 44691
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
United States, Oregon
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Providence Cancer Center at PMCC
Medford, Oregon, United States, 97504
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
United States, West Virginia
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States, 53295
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Jeffrey Bradley, MD

Mallinckrodt Institute of Radiology at Washington University Medical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Bradley JD, Graham M, Suzanne S, et al.: Phase I results of RTOG L-0117: a phase I/II dose intensification study using 3DCRT and concurrent chemotherapy for patients with inoperable NSCLC. [Abstract] J Clin Oncol 23 (Suppl 16): A-7063, 636s, 2005.

Responsible Party:	Radiation Therapy Oncology Group ( Walter John Curran, Jr )
Study ID Numbers:	CDR0000068850, RTOG-L-0117
Study First Received:	September 13, 2001
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00023673 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009