Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments carboplatin, paclitaxel, radiation therapy
Phase phase 1
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date March 2012
End date March 2017
Trial size 24 participants
Trial identifier NCT01486602, CALGB 31102, CDR0000719011, NCI-2012-00087, U10CA031946, U10CA180821

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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).
carboplatin
IV
paclitaxel
IV
radiation therapy
Defined per the protocol

Primary Outcomes

Measure
Maximum-tolerated RT dose fraction
time frame: Up to 28 months

Secondary Outcomes

Measure
Radiographic response
time frame: Up to 5 years
Metabolic response
time frame: Up to 5 years
Rates of progression: local/regional/distant
time frame: Up to 5 years
Progression-free survival
time frame: Up to 5 years
Overall survival
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer
Description PRIMARY OBJECTIVES: I. To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy. SECONDARY OBJECTIVES: I. To evaluate the rate of radiographic response to treatment. II. To estimate the rates of progression: local/regional/distant. III. To estimate the progression-free survival. IV. To estimate the overall survival. OUTLINE: This is a dose-escalation study of accelerated hypofractionated radiotherapy. CONCURRENT THERAPY: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4-5.5 weeks. CONSOLIDATION THERAPY: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month, every 3 months for 2 years, and then every 6 months for 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.