Status:
COMPLETED
Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the...
Detailed Description
OBJECTIVES: Primary * Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00227539
Start Date
July 1 2005
End Date
November 1 2013
Last Update
May 9 2017
Active Locations (2)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
2
University of Washington School of Medicine
Seattle, Washington, United States, 98195