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 - Full Text View

Purpose

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	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18	Phase 2


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Renato Martins, University of Washington:

Primary Outcome Measures:

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:

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.
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.


Enrollment:	25
Study Start Date:	July 2005
Study Completion Date:	November 2013
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Neoadjuvant therapy, PET scan and surgery	Drug: cisplatin Drug: pemetrexed disodium Procedure: adjuvant therapy Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227539

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


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 )
Study First Received:	September 26, 2005
Results First Received:	February 14, 2017
Last Updated:	March 31, 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

ClinicalTrials.gov processed this record on August 21, 2017