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

NCT00004253 | Unknown Phase 2

• 4 other identifiers: CDR0000067500BHM-L1BHM-99-64NCI-V99-1582
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

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

Interventions

carboplatin DRUG

paclitaxel DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Baptist Health South Florida: lead

Study Sites (2)

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176-2197, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Andre A. Abitbol, MD

  Baptist Health South Florida

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: July 23, 2003
• Study Start: March 1, 2000
• Last Updated: December 18, 2013

Record last verified: 2002-11

Locations

US (2)