Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in
predicting radiological and pathological response in patients treated with pemetrexed
disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung
cancer (NSCLC).
Secondary
- Determine the safety of cisplatin and pemetrexed disodium in these patients.
- Determine the radiographic response rate, duration of response, and time to progression
in patients treated with cisplatin and pemetrexed disodium.
OUTLINE: This is a multicenter study.
- Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients
undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen,
and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of
rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at
three points during the study: 4 weeks prior to treatment, after the first cycle of
treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical
resection of the tumor.
- Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV
over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IB, II, IIIA, or IIIB (T4, N0-1) disease
- Staging must have been performed 4 weeks prior to study entry with a CT scan of
chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission
tomography (PET) scan
- Mediastinal evaluation and staging based on combination of CT scan and FDG-PET
results
- If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by
brain MRI
- Measurable and resectable disease
- T4 lesions must be resectable
- Eligible for curative surgery
- No malignant pleural effusion
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,250/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3.0 times ULN
Renal
- Creatinine clearance ≥ 45 mL/min
Pulmonary
- Adequate pulmonary reserve to undergo surgery
- Predicted FEV_1 > 0.8 L after resection
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment
- Able to take corticosteroids
- Able to take folic acid or vitamin B_12 supplements
- No other malignancy within the past 5 years except nonmelanoma skin cancer or
noninvasive cervical cancer
- No concurrent serious or uncontrolled disorder that would preclude study
participation
- No type I diabetes mellitus
- Type II diabetes mellitus allowed if glucose is 80-150 mg/dL
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent prophylactic filgrastim (G-CSF)
- No concurrent thrombopoiesis-stimulating agents
Chemotherapy
- At least 5 years since prior chemotherapy
Endocrine therapy
- No concurrent anticancer hormonal therapy
Radiotherapy
- No prior radiotherapy to the chest
- No concurrent curative or palliative radiotherapy
Surgery
- Not specified
Other
- At least 30 days since prior non-FDA-approved or investigational agents
- At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8
days for long-acting agents [e.g., piroxicam])
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Positron emission tomography as a predictor of response measured by the decrease in standard uptake variable (SUV) after 1 course of therapy
Outcome Time Frame:
Between days 18 and 22 prior to second chemotherapy infusion
Safety Issue:
No
Principal Investigator
Renato Martins, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seattle Cancer Care Alliance
Authority:
United States: Federal Government
Study ID:
6228
NCT ID:
NCT00227539
Start Date:
July 2005
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Washington School of Medicine | Seattle, Washington 98195 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
