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

Study Description

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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 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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: cisplatin; Drug: pemetrexed disodium; Procedure: adjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: fludeoxyglucose F 18	Phase 2

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 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
Study Start Date :	July 2005
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	November 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Neoadjuvant therapy, PET scan and surgery	Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18

Outcome Measures

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Primary Outcome Measures :

1. Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy [ Time Frame: Between days 18 and 22 prior to second chemotherapy infusion ]
   Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy

Secondary Outcome Measures :

1. Safety of Neoadjuvant Chemotherapy [ Time Frame: Up to 4 weeks after last dose of chemotherapy ]
   The number of patients that experienced a grade 3 or higher adverse event.
2. Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate [ Time Frame: Up to 4 weeks after last dose of chemotherapy ]
   The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
University of Washington School of Medicine
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Renato Martins, MD, MPH	Seattle Cancer Care Alliance

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Renato Martins, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier:	NCT00227539 History of Changes
Other Study ID Numbers:	6228; P30CA015704 ( U.S. NIH Grant/Contract ); UWCC-6228; UWCC-UW-6228; UW-04033; LILY-UW-04033; CDR0000441239 ( Registry Identifier: PDQ )
First Posted:	September 28, 2005
Results First Posted:	April 4, 2017
Last Update Posted:	May 9, 2017
Last Verified:	February 2017

Keywords provided by Renato Martins, University of Washington:

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

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms	Cisplatin; Pemetrexed; Fluorodeoxyglucose F18; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Radiopharmaceuticals