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

NCT ID: NCT00004253

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31

Brief Summary

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.

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.

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baptist Health South Florida

OTHER

Sponsor Role: lead

Principal Investigators

Andre A. Abitbol, MD

Role: STUDY_CHAIR

Baptist Health South Florida

Locations

Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

BHM-L1

Identifier Type: -

Identifier Source: secondary_id

BHM-99-64

Identifier Type: -

Identifier Source: secondary_id

NCI-V99-1582

Identifier Type: -

Identifier Source: secondary_id

CDR0000067500

Identifier Type: -

Identifier Source: org_study_id