Hypofractionated Proton Beam Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Stage II-III Non-Small Cell Lung Cancer

NCT02172846 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 201404047
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of hypofractionated proton beam radiation therapy when given together with paclitaxel and carboplatin in treating patients with stage II-III non-small cell lung cancer. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Giving proton beam radiation therapy at higher doses over fewer days (hypofractionation) may improve local control of the tumor. Giving hypofractionated proton beam radiation therapy with chemotherapy may be a better treatment for non-small cell lung cancer

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of hypofractionated proton beam therapy (PBT) with chemotherapy

  Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used. The MTD will be chosen as the dose that yields a posterior estimate of toxicity closest to 20% while being between 15% and 25%. Dose limiting toxicity will be defined as toxicity that occurs within 6 months from the start of treatment, is possibly, probably or definitely related to treatment, and is related to the following Grade 3-5 pericardial effusion, pericarditis, restrictive cardiomyopathy, hemorrhage (pulmonary or upper respiratory), excluding nose, larynx, or pharynx, brachial plexopathy, laryngeal nerve dysfunction, myelitis, phrenic nerve dysfunction , atelectasis (grade 4-5 only), pulmonary fistula, hypoxia (provided grade 3 is worse than baseline), obstruction/stenosis of the airway, pleural effusion, pneumonitis, pulmonary fibrosis Grade 4-5 dysphagia, esophagitis, esophageal fistula, obstruction, perforation, stricture/stenosis, ulcer, and hemorrhage Grade 4-5 skin Any grade 5

  Up to 6 months

Secondary Outcomes (2)

• Incidence of acute toxicities

  Up to 6 months

• Incidence of late toxicities as defined

  Up to 1 year

Study Arms (1)

Treatment (PBT, paclitaxel, and carboplatin)

EXPERIMENTAL

CHEMORADIATION THERAPY: * PBT daily 5 days a week over 3 weeks for a total of 15 fractions * Paclitaxel intravenously (IV) over 1 hour weekly for 3 weeks * Carboplatin intravenously (IV) over 30 minutes weekly for 3 weeks. CONSOLIDATION CHEMOTHERAPY (B=beginning 4-6 weeks after completion of radiation therapy, patients may receive): * Paclitaxel IV over 1 hour on day 1 * Carboplatin IV over 30 minutes on day 1 * At the discretion of the treating physician * Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Radiation: Proton beam radiation therapy (PBT); Drug: Paclitaxel; Drug: Carboplatin

Interventions

Proton beam radiation therapy (PBT) RADIATION

Treatment (PBT, paclitaxel, and carboplatin)

Paclitaxel DRUG

Also known as: Abraxane®, Onxol®, Taxol®

Treatment (PBT, paclitaxel, and carboplatin)

Carboplatin DRUG

Also known as: Paraplatin®, CBDCA

Treatment (PBT, paclitaxel, and carboplatin)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically proven diagnosis of non-small cell lung cancer.
• Clinical AJCC stage II-III (AJCC, 7th ed.) with plans to be treated with concurrent chemoradiotherapy.
• Recurrent non-small cell lung cancer is allowed, provided the intent of the current treatment is curative and there has been no prior radiation to the thorax.
• Prior chemotherapy, immunotherapy, or targeted therapy is permitted as long as patients have recovered from prior toxicities to grade ≤ 1
• Appropriate stage for protocol entry based upon the following minimum diagnostic workup:
• History/physical examination within 30 days prior to registration;
• FDG-PET/CT scan for staging within 60 days prior to registration;
• MRI scan with contrast of the brain (preferred) or CT scan of the brain with contrast within 60 days prior to registration.
• Zubrod Performance Status 0-2 within 30 days prior to registration.
• Age ≥ 18 years.
• CBC/differential obtained within 30 days prior to registration, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
• Platelets ≥ 100,000 cells/mm3;
• Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
• AST and ALT ≤ 1.5 upper limit of normal within 30 days prior to registration.

You may not qualify if:

• Severe, active comorbidity, defined as follows:
• Unstable angina, history of myocardial infarction and/or congestive heart failure requiring hospitalization within the last 6 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol;
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Prior radiotherapy to the thorax.
• Currently receiving any other investigational agents.
• Pregnant or breastfeeding.
• Presence of a cardiac pacemaker (due to the risk created by the proton magnet).
• Both men and women and members of all races and ethnic groups are eligible for this trial.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Proton Therapy; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Cliff Robinson, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

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: June 20, 2014
• First Posted: June 24, 2014
• Study Start: May 22, 2014
• Primary Completion: August 23, 2016
• Study Completion: October 2, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)