Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery - Full Text View

Sponsor:	Baptist Health South Florida
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004253

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.

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

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

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

Study Start Date:

March 2000

Detailed Description:

OBJECTIVES:

Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT).
Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients.
Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines.
Determine the feasibility of patient-specific dose escalation using this regimen in these patients.
Determine the quality of life and symptom distress in these patients on this regimen.

OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT).

Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks.

Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels.

Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months.

Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Patients with unresected locally advanced non-small cell lung cancer
- Stage II, IIIA, or IIIB
- No evidence of hematogenous metastases
No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure)
No intrathoracic tumor recurrence following resection

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 70-100%

Life expectancy:

Not specified

Hematopoietic:

Absolute granulocyte count at least 2,000/mm3
Platelet count at least 130,000/mm3
Hemoglobin at least 10 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 active or symptomatic cardiac disease
No acute myocardial infarction within the past 6 months
No angina
No congestive heart failure
No uncontrolled arrhythmias
Cardiac ejection fraction greater than 50%

Pulmonary:

FEV1 at least 1.25 L AND
DLCO at least 50% predicted

Other:

Not pregnant
Fertile patients must use effective contraception
Weight loss no greater than 5% within 3 months of diagnosis
No other prior malignancy within the past 3 years except nonmelanomatous skin cancer

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004253

Locations

United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136

Sponsors and Collaborators

Baptist Health South Florida

Investigators

Study Chair:

Andre A. Abitbol, MD

Baptist Health South Florida

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000067500, BHM-L1, BHM-99-64, NCI-V99-1582
Study First Received:	January 28, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004253 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small 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 February 08, 2010