Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00227539
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : April 4, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Renato Martins, University of Washington

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Results First Submitted Date  ICMJE February 14, 2017
Results First Posted Date  ICMJE April 4, 2017
Last Update Posted Date May 9, 2017
Study Start Date  ICMJE July 2005
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: cisplatin
  • Drug: pemetrexed disodium
  • Procedure: adjuvant therapy
  • Procedure: therapeutic conventional surgery
  • Radiation: fludeoxyglucose F 18
Study Arms  ICMJE Experimental: Neoadjuvant therapy, PET scan and surgery
Interventions:
  • Drug: cisplatin
  • Drug: pemetrexed disodium
  • Procedure: adjuvant therapy
  • Procedure: therapeutic conventional surgery
  • Radiation: fludeoxyglucose F 18
Publications * Romine PE, Martins RG, Eaton KD, Wood DE, Behnia F, Goulart BHL, Mulligan MS, Wallace SG, Kell E, Bauman JE, Patel SA, Vesselle HJ. Long term follow-up of neoadjuvant chemotherapy for non-small cell lung cancer (NSCLC) investigating early positron emission tomography (PET) scan as a predictor of outcome. BMC Cancer. 2019 Jan 14;19(1):70. doi: 10.1186/s12885-019-5284-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2012)
25
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227539
Other Study ID Numbers  ICMJE 6228
P30CA015704 ( U.S. NIH Grant/Contract )
UWCC-6228
UWCC-UW-6228
UW-04033
LILY-UW-04033
CDR0000441239 ( Registry Identifier: PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Renato Martins, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Renato Martins, MD, MPH Seattle Cancer Care Alliance
PRS Account University of Washington
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP