CompletedPhase 2NCT00227539

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

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.

Checked against the public recordLast updated May 9, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations2
SponsorUniversity of Washington
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Washington
Interventions being studied
Drug: cisplatin; Drug: pemetrexed disodium; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Seattle Cancer Care AllianceSeattle, Washington
  • University of Washington School of MedicineSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 9, 2017. Always confirm current availability with the study team.

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