Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

NCT01486602 | Completed Phase 1

• 5 other identifiers: CALGB 31102CDR0000719011NCI-2012-00087U10CA031946U10CA180821
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 11

Brief Summary

This phase I trial studies the side effects and the best dose of hypofractionated radiation therapy when given together with chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hypofractionated radiation therapy together with chemotherapy may kill more tumor cells.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum-tolerated RT dose fraction

  Up to 28 months

Secondary Outcomes (5)

• Radiographic response

  Up to 5 years

• Metabolic response

  Up to 5 years

• Rates of progression: local/regional/distant

  Up to 5 years

• Progression-free survival

  Up to 5 years

• Overall survival

  Up to 5 years

Study Arms (1)

Concurrent therapy + consolidation therapy

EXPERIMENTAL

Concurrent Therapy (1 cycle = 14 days, Cycles 1-3): Patients will receive paclitaxel 45 mg/m\^2 by IV over 1 hour weekly followed by carboplatin AUC 2 by IV over 30-60 minutes for 4 weeks (there will be no chemotherapy during Cycle 3). Patients will receive radiotherapy concurrently for up to 5.5 weeks, depending on the cohorts the patient is registered defined per the protocol. Consolidation Therapy (1 cycle = 21 days, Cycles 4-5): Four weeks following the end of radiotherapy patients will receive paclitaxel 200 mg/m\^2 by IV over 3 hours followed by carboplatin AUC 6 by IV over 30-60 minutes on day 1 of each 21 day cycle for a total of 2 cycles (days 1 and 22).

Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy

Interventions

carboplatin DRUG

IV

Concurrent therapy + consolidation therapy

paclitaxel DRUG

IV

Concurrent therapy + consolidation therapy

radiation therapy RADIATION

Defined per the protocol

Concurrent therapy + consolidation therapy

Eligibility Criteria

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

1. Histologically or cytologically documented non-small cell lung cancer 2. Stage IIIA or IIIB non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) version 7; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible 3. Thoracic disease without supraclavicular or contralateral hilar involvement 4. When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; exudative pleural effusions are excluded regardless of cytology; patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible 5. No prior radiotherapy or chemotherapy for NSCLC 6. No prior mediastinal or thoracic radiotherapy 7. Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible 8. Patients must have measurable disease * Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral CT scan * Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 10. No patients that are known to be pregnant or nursing 11. Granulocytes ≥ 1,500/μl Platelet count ≥ 100,000/μl Bilirubin ≤ 1.5 times upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxalo-acetic transaminase \[SGOT\]) ≤ 2.0 times ULN Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance \>= 70 mL/min FEV-1 ≥ 1.2 L/sec or 50% predicted

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Moores University of California San Diego Cancer Center

La Jolla, California, 92093-0987, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7305, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1030, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Vermont

Burlington, Vermont, 05401, 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

• James J. Urbanic, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: March 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 16, 2018
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

US (11)