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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00227539
First received: September 26, 2005
Last updated: January 6, 2014
Last verified: January 2014

September 26, 2005
January 6, 2014
July 2005
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00227539 on ClinicalTrials.gov Archive Site
  • Safety of neoadjuvant chemotherapy [ Time Frame: Up to 4 weeks after last dose of chemotherapy ] [ Designated as safety issue: Yes ]
  • Efficacy of neoadjuvant chemotherapy as measured by radiologic response rate [ Time Frame: Up to 4 weeks after last dose of chemotherapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for 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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: pemetrexed disodium
  • Procedure: adjuvant therapy
  • Procedure: therapeutic conventional surgery
  • Radiation: fludeoxyglucose F 18
Experimental: Neoadjuvant therapy, PET scan and surgery
Interventions:
  • Drug: cisplatin
  • Drug: pemetrexed disodium
  • Procedure: adjuvant therapy
  • Procedure: therapeutic conventional surgery
  • Radiation: fludeoxyglucose F 18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227539
6228, P30CA015704, UWCC-6228, UWCC-UW-6228, UW-04033, LILY-UW-04033, CDR0000441239
Not Provided
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Renato Martins, MD, MPH Seattle Cancer Care Alliance
University of Washington
January 2014

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