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:	Primary Purpose: 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
Primary Completion Date:	March 2010 (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

Show 41 Study Locations

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, Bae K, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. Primary Analysis of the Phase II Component of 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: RTOG 0117. J Clin Oncol. 2010 Apr 5; [Epub ahead of print]

Bradley JD, Moughan J, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. A phase I/II radiation dose escalation study with concurrent chemotherapy for patients with inoperable stages I to III non-small-cell lung cancer: phase I results of RTOG 0117. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):367-72.

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:	Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00023673 History of Changes
Other Study ID Numbers:	CDR0000068850, RTOG-L-0117
Study First Received:	September 13, 2001
Last Updated:	May 14, 2010
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:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012