Malignant Pleural Effusion, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Conditions
Brief summary
This phase II trial studies how well fludeoxyglucose F 18 (FDG)-labeled positron emission tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel, carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy and allow doctors to plan better treatment
Detailed description
PRIMARY OBJECTIVES: I. Assess the response rate in patients who do not demonstrate an early response to carboplatin/paclitaxel as determined by FDG-PET (initial non-responders) who are subsequently treated with three additional courses of docetaxel/gemcitabine. SECONDARY OBJECTIVES: I. Evaluate the ability of FDG-PET to predict response to therapy as measured by computed tomography (CT). II. Evaluate the early and late changes in tumor FDG uptake (change in standardized uptake value \[SUV\]) in all patients and correlate with overall survival (OS). OUTLINE: All patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG-PET/CT scan between days 18-21. Patients are then assigned to 1 of 2 treatment groups. GROUP I (Responders): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity. GROUP II (Initial non-responders): Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG-PET/CT scan between days 18-21 of course 2. After completion of study treatment, patients are followed up at days 81-84 and then periodically thereafter.
Interventions
DRUGcarboplatin
Given IV
DRUGdocetaxel
Given IV
DRUGgemcitabine hydrochloride
Given IV
DRUGpaclitaxel
Given IV
PROCEDUREcomputed tomography
Undergo FDG PET/CT
PROCEDUREpositron emission tomography
Undergo FDG PET/CT
RADIATIONfludeoxyglucose F 18
Given IV
Correlative studies
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically confirmed NSCLC; patients must have stage IIIB with malignant pleural effusion or with nodal disease so extensive that it is not amenable to radiotherapy with curative intent, or stage IV disease, as defined by the American Joint Committee on Cancer (AJCC) cancer staging handbook, 6th Edition (2002) * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (\>= 10 mm with spiral CT scan); patients' baseline FDG-PET scan must demonstrate a target lesion with SUV \>= 2 x background and SUV \> 3 * All patients must not have received treatment with conventional cytotoxic chemotherapy for NSCLC; patients may have had prior radiotherapy or may have been treated with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) (i.e. erlotinib or gefitinib); one week must have elapsed after discontinuation, prior to the initial PET scan for patients previously treated with a TKI; patients who receive radiotherapy must have recovered from the side effects of therapy (except alopecia) and have measurable disease (target lesion) outside of the radiation field * Life expectancy \>= 3 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 2 x institutional ULN (\< 5 x ULN for patients with liver metastases) * Creatinine =\< 1.5 x ULN OR creatinine clearance \>= 40 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Patients must have baseline FDG-PET and CT scans performed at the University of Washington (UW)/Seattle Cancer Care Alliance (SCCA) within two weeks from the start of chemotherapy * Asymptomatic patients with clinically stable brain metastases (treated or untreated) are allowed * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout treatment and for 30 days following the last dose of chemotherapy * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Patients who have received EGFR TKI (i.e. erlotinib or gefitinib) within one week prior to entering the study * Patients may not be receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition agents used in the study * Inability or unwillingness to take corticosteroids, which are required pre-medications for the chemotherapies in this trial * Diabetes requiring insulin for management * Patients must weigh less than 400 lbs * Patients with post-obstructive pneumonia or lobar collapse * Significant neuropathy (common toxicity criteria \[CTC\] grade \> 2), as both the paclitaxel and docetaxel have potential for neurotoxicity * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breastfeeding women * Patients with a detectable second malignancy are excluded, as this could confound tumor evaluation and affect patient survival * Patients who are likely to need palliative radiation therapy for painful bony metastases, impending fractures, or hemoptysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (Patients That Achieve a CR or PR) | At the end of 4 cycles of treatment, up to 24 weeks. | Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chemotherapy Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.
carboplatin: Given IV
docetaxel: Given IV
gemcitabine hydrochloride: Given IV
paclitaxel: Given IV
computed tomography: Undergo FDG PET/CT
positron emission tomography: Undergo FDG PET/CT
fludeoxyglucose F 18: Given IV
imaging biomarker analysis: Correlative studies | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 5 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 60 years |
| Gender Female | 22 Participants |
| Gender Male | 24 Participants |
| Region of Enrollment United States | 46 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 46 |
| serious Total, serious adverse events | 3 / 46 |
Outcome results
Primary
Overall Response Rate (Patients That Achieve a CR or PR)
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: At the end of 4 cycles of treatment, up to 24 weeks.
Population: All patients that signed consent and received at least one cycle of chemotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chemotherapy | Overall Response Rate (Patients That Achieve a CR or PR) | 13 participants |