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FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00564733
First received: November 27, 2007
Last updated: May 7, 2013
Last verified: May 2013

November 27, 2007
May 7, 2013
October 2007
September 2011   (final data collection date for primary outcome measure)
Response rate in patients who do not demonstrate an early response to carboplatin/paclitaxel as determined by FDG-PET (initial non-responders) who are subsequently treated with three courses of docetaxel/gemcitabine as measured by CT [ Time Frame: At the end of 4 courses of treatment ] [ Designated as safety issue: No ]
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Response rate in initial non-responders
Complete list of historical versions of study NCT00564733 on ClinicalTrials.gov Archive Site
  • Proportion of patients achieving response as measured by CT [ Time Frame: At the end of 4 courses of treatment ] [ Designated as safety issue: No ]
  • Early and late changes in tumor FDG uptake (delta SUV) [ Time Frame: After 1 and 4 courses of treatment ] [ Designated as safety issue: No ]
  • Correlation between tumor FDG uptake and overall survival [ Time Frame: At 6 and 12 months post-treatment ] [ Designated as safety issue: No ]
  • Ability of fludeoxyglucose F 18 (FDG) positron emission tomography to predict response to therapy as measured by CT
  • The early and late changes in tumor FDG uptake and correlation with overall survival
Not Provided
Not Provided
 
FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer

This phase II trial studies how well fludeoxyglucose F 18 (FDG)-labeled positron emission tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel, carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy and allow doctors to plan better treatment

PRIMARY OBJECTIVES:

I. Assess the response rate in patients who do not demonstrate an early response to carboplatin/paclitaxel as determined by FDG-PET ("initial non-responders") who are subsequently treated with three additional courses of docetaxel/gemcitabine.

SECONDARY OBJECTIVES:

I. Evaluate the ability of FDG-PET to predict response to therapy as measured by computed tomography (CT).

II. Evaluate the early and late changes in tumor FDG uptake (change in standardized uptake value [SUV]) in all patients and correlate with overall survival (OS).

OUTLINE: All patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG-PET/CT scan between days 18-21.

Patients are then assigned to 1 of 2 treatment groups.

GROUP I (Responders): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.

GROUP II (Initial non-responders): Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG-PET/CT scan between days 18-21 of course 2.

After completion of study treatment, patients are followed up at days 81-84 and then periodically thereafter.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malignant Pleural Effusion
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Drug: docetaxel
    Given IV
    Other Names:
    • RP 56976
    • Taxotere
    • TXT
  • Drug: gemcitabine hydrochloride
    Given IV
    Other Names:
    • dFdC
    • difluorodeoxycytidine hydrochloride
    • gemcitabine
    • Gemzar
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Procedure: computed tomography
    Undergo FDG PET/CT
    Other Name: tomography, computed
  • Procedure: positron emission tomography
    Undergo FDG PET/CT
    Other Names:
    • FDG-PET
    • PET
    • PET scan
    • tomography, emission computed
  • Radiation: fludeoxyglucose F 18
    Given IV
    Other Names:
    • 18FDG
    • FDG
  • Other: imaging biomarker analysis
    Correlative studies
  • Experimental: Group I (responders)
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients then receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: carboplatin
    • Drug: docetaxel
    • Drug: gemcitabine hydrochloride
    • Drug: paclitaxel
    • Procedure: computed tomography
    • Procedure: positron emission tomography
    • Radiation: fludeoxyglucose F 18
    • Other: imaging biomarker analysis
  • Experimental: Group II (initial non-responders)
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.
    Interventions:
    • Drug: carboplatin
    • Drug: docetaxel
    • Drug: gemcitabine hydrochloride
    • Drug: paclitaxel
    • Procedure: computed tomography
    • Procedure: positron emission tomography
    • Radiation: fludeoxyglucose F 18
    • Other: imaging biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed NSCLC; patients must have stage IIIB with malignant pleural effusion or with nodal disease so extensive that it is not amenable to radiotherapy with curative intent, or stage IV disease, as defined by the American Joint Committee on Cancer (AJCC) cancer staging handbook, 6th Edition (2002)
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (>= 10 mm with spiral CT scan); patients' baseline FDG-PET scan must demonstrate a target lesion with SUV >= 2 x background and SUV > 3
  • All patients must not have received treatment with conventional cytotoxic chemotherapy for NSCLC; patients may have had prior radiotherapy or may have been treated with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) (i.e. erlotinib or gefitinib); one week must have elapsed after discontinuation, prior to the initial PET scan for patients previously treated with a TKI; patients who receive radiotherapy must have recovered from the side effects of therapy (except alopecia) and have measurable disease (target lesion) outside of the radiation field
  • Life expectancy >= 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =< 2 x institutional ULN (< 5 x ULN for patients with liver metastases)
  • Creatinine =< 1.5 x ULN OR creatinine clearance >= 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Patients must have baseline FDG-PET and CT scans performed at the University of Washington (UW)/Seattle Cancer Care Alliance (SCCA) within two weeks from the start of chemotherapy
  • Asymptomatic patients with clinically stable brain metastases (treated or untreated) are allowed
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout treatment and for 30 days following the last dose of chemotherapy
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have received EGFR TKI (i.e. erlotinib or gefitinib) within one week prior to entering the study
  • Patients may not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition agents used in the study
  • Inability or unwillingness to take corticosteroids, which are required pre-medications for the chemotherapies in this trial
  • Diabetes requiring insulin for management
  • Patients must weigh less than 400 lbs
  • Patients with post-obstructive pneumonia or lobar collapse
  • Significant neuropathy (common toxicity criteria [CTC] grade > 2), as both the paclitaxel and docetaxel have potential for neurotoxicity
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding women
  • Patients with a detectable second malignancy are excluded, as this could confound tumor evaluation and affect patient survival
  • Patients who are likely to need palliative radiation therapy for painful bony metastases, impending fractures, or hemoptysis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00564733
6566, NCI-2010-00606
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Keith Eaton Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
May 2013

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