Phase 2
N=25
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
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00227539 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Apr 2017
Primary outcome: Primary: Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); pemetrexed disodium (Drug); adjuvant therapy (Procedure); therapeutic conventional surgery (Procedure); fludeoxyglucose F 18 (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy |
11 | — |
| SECONDARY Safety of Neoadjuvant Chemotherapy |
10 | — |
| SECONDARY Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate |
20 | — |
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 best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well PET works 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00227539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.