Feasibility Study of SBRT Plus Chemotherapy for Non-Small Cell Lung Carcinoma

NCT02319889 | Terminated Early Phase 1 DMC FDA Drug

• 4 other identifiers: CASE2514NCI-2014-02276CASE 2514P30CA043703
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies stereotactic body radiation therapy followed by combination chemotherapy in treating patients with non-small cell lung cancer. Stereotactic body radiation therapy is a specialized radiation therapy that delivers one to five high doses of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue than conventional radiation. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, 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 stereotactic body radiation therapy, followed by carboplatin, and paclitaxel albumin-stabilized nanoparticle formulation may kill more tumor cells and result in a better and more durable response than conventional radiation and chemotherapy. The purpose of this study is to test the safety of this approach prior to larger studies.

Conditions

Stage I Non-Small Cell Lung Cancer; Stage II Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with prohibitive dose limiting toxicities

  Number of participants that miss two or more cycles of treatment due to toxicities

  Up to 1 year

Secondary Outcomes (1)

• 1 year progression free survival (PFS)

  1 year

Study Arms (1)

Treatment (SBRT, carboplatin, Abraxane)

EXPERIMENTAL

Patients undergo Stereotactic Body Radiotherapy every other day for up to 14 days for a total of 5 fractions. After a break period of about 30 days, patients will then start chemotherapy. Patients will receive carboplatin IV over 30-40 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Radiation: Stereotactic Body Radiotherapy; Drug: Carboplatin; Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Interventions

Stereotactic Body Radiotherapy RADIATION

Undergo SBRT

Also known as: SBRT, Stereotactic External Beam Irradiation, Stereotactic Radiation Therapy, Stereotactic Radiotherapy

Treatment (SBRT, carboplatin, Abraxane)

Carboplatin DRUG

Given IV

Also known as: Paraplatin

Treatment (SBRT, carboplatin, Abraxane)

Paclitaxel Albumin-Stabilized Nanoparticle Formulation DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane

Treatment (SBRT, carboplatin, Abraxane)

Eligibility Criteria

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

You may qualify if:

• Patients must have pathologic diagnosis of non-small cell lung carcinoma (NSCLC), by either histologic biopsy, or cytologic evidence; highly suspicious cytology (i.e. abnormal cells suspicious for malignancy) is acceptable, in the setting of a strongly positive computed tomography (CT)/positron emission tomography (PET) (standardized uptake value \[SUV\] \> 5.0)
• Patients must be considered appropriate for stereotactic body radiation therapy (SBRT); this is determined on an individualized basis, by the prospective multidisciplinary tumor board, that includes representation from surgical, radiation and medical oncology; criteria for appropriateness for SBRT include all of the following:
• Stage I/II non-small cell lung carcinoma (NSCLC) - no evidence of distant metastases (patients with up to three lung nodules may be considered to have 'multiple primary' lung cancer rather than metastatic lung cancer and thus will be eligible; if a lymph node(s) ≥ 2 cm and/or PET-SUV ≥ 4.0 is identified, biopsy must be performed (and be negative) for the patient to be eligible; patients thought to have M1b disease, or malignant pleural/pericardial effusions are not eligible
• Staging including CT chest, PET/CT must be up-to-date, i.e. within 6 weeks prior to registration; brain imaging (contrast-enhanced magnetic resonance imaging \[MRI\] or CT) is suggested for all patients, but is only mandatory for patients with abnormal neurologic exam
• Tumor size ≤ 7 cm in greatest dimension based upon an up-to-date CT (and/or CT/PET) within 6 weeks prior to enrollment onto the study; radiation therapy treatment planning imaging is acceptable)
• The patient must not be a candidate for (or declines because of high risk) surgical resection because of medical comorbidity/risk; the patient must have undergone an evaluation by an experienced thoracic surgeon within 12 weeks prior to registration; standard justification criteria may include forced expiratory volume in 1 second (FEV1) \< 40% predicted; predicted postoperative FEV1 ≤ 30% predicted; diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 60% predicted; pulmonary hypertension (estimated ≥ 40 mm Hg); poor cardiac function (ejection fraction \[EF\] ≤ 40%); Medical Research Council (MRC) dyspnea scale ≥ 3 (corresponds to inability to walk at least 100 yards without rest); baseline hypoxemia (partial pressure of oxygen \[pO2\] ≤ 55 mg HG and/or pulse oxygen \[ox\] \< 88%), baseline hypercapnia (carbon dioxide \[CO2\] ≥ 45 mm Hg; there are also other, less objective criteria, including severe end-organ damage from diabetes/hypertension, severe atherosclerotic disease (heart, brain, aorta, peripheral artery)
• Tumor(s) must be in a location/configuration such that risk of fistula is considered relatively low; this means that there can be no evidence of tumor invasion of a major (lobar/hilar) pulmonary vessel(s), aorta, vena cava, trachea or mainstem bronchus or esophagus; additional studies may be needed to assess this, including CT angiogram, MRI, bronchoscopy, esophagoscopy
• One or more of the following "risk" criteria for failure with conventional SBRT treatment alone:
• Peripheral tumor ≥ 4 cm in any dimension
• Central tumor (i.e. gross tumor within 2 cm of a major bronchus/vessel, or heart/pericardium), including hilar lymph node(s)
• Multiple tumors (i.e. satellitosis-defined T3-4, or bilateral synchronous primary lung cancer; note that the maximum number of total lesions allowable on this study for treatment with SBRT is 3 (Three), and all lesions must be amenable to SBRT and treated with SBRT on this study; note that it is not necessary for all lesions felt to be malignant to be biopsied
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Hemoglobin ≥ 9.0 g/dl
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000 cells/mcL

You may not qualify if:

• Prior treatment toxicities (i.e. any toxicity from treatment of a previous cancer ) must be resolved to ≤ grade 1 according to National Cancer Institute (NCI) CTCAE version 4.0 (except alopecia)
• Patients who are receiving any other investigational agents
• Patients with prior invasive malignancy within two years of enrollment are excluded
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) or other agents used in this study
• Patients with severe cardiac disease including symptomatic congestive heart failure, unstable angina, or have experience an acute myocardial infarction within the past 6 months; please note: patients with chronic obstructive pulmonary disease (COPD) are not excluded
• Pregnant or breastfeeding women are excluded from this study; breastfeeding should be discontinued
• Known human immunodeficiency virus (HIV)-positive patients are ineligible

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Carboplatin; Taxes; Albumin-Bound Paclitaxel

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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Mitchell Machtay, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 18, 2014
• Study Start: February 2, 2016
• Primary Completion: July 6, 2016
• Study Completion: January 19, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)