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Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer



- 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).


- 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


- 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

- 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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,250/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 3.0 times ULN


- Creatinine clearance ≥ 45 mL/min


- Adequate pulmonary reserve to undergo surgery

- Predicted FEV_1 > 0.8 L after resection


- 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

- No type I diabetes mellitus

- Type II diabetes mellitus allowed if glucose is 80-150 mg/dL


Biologic therapy

- No concurrent immunotherapy

- No concurrent prophylactic filgrastim (G-CSF)

- No concurrent thrombopoiesis-stimulating agents


- At least 5 years since prior chemotherapy

Endocrine therapy

- No concurrent anticancer hormonal therapy


- No prior radiotherapy to the chest

- No concurrent curative or palliative radiotherapy


- Not specified


- 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:


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:


Principal Investigator

Renato Martins, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seattle Cancer Care Alliance


United States: Federal Government

Study ID:




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



University of Washington School of Medicine Seattle, Washington  98195
Seattle Cancer Care Alliance Seattle, Washington  98109