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CompletedNCT00564733Updated Feb 10, 2017Results posted

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

A Phase 2 interventional study of carboplatin and docetaxel in Malignant Pleural Effusion, Stage IIIB Non-small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, sponsored by University of Washington. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Malignant Pleural Effusion
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 55 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Chemotherapy

    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT (fludeoxyglucose F 18 positron emission tomography/computed tomography) scan between days 18-21. The FDG PET/CT is an imaging biomarker analysis. Patients that are responding to treatment receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients that are not responding to chemotherapy per FDG PET 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. Non-responding patients undergo an additional FDG PET/CT scan between days 18-21 of course 2.

    Drug: carboplatin · Drug: docetaxel · Drug: gemcitabine hydrochloride · Drug: paclitaxel · Procedure: computed tomography · Procedure: positron emission tomography · Radiation: fludeoxyglucose F 18 · Other: imaging biomarker analysis

Interventions

  • Drugcarboplatin

    Given IV

    Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

  • Drugdocetaxel

    Given IV

    Also known as: RP 56976, Taxotere, TXT

  • Druggemcitabine hydrochloride

    Given IV

    Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

  • Drugpaclitaxel

    Given IV

    Also known as: Anzatax, Asotax, TAX, Taxol

  • Procedurecomputed tomography

    Undergo FDG PET/CT

    Also known as: tomography, computed

  • Procedurepositron emission tomography

    Undergo FDG PET/CT

    Also known as: FDG-PET, PET, PET scan, tomography, emission computed

  • Radiationfludeoxyglucose F 18

    Given IV

    Also known as: 18FDG, FDG

  • Otherimaging biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (Patients That Achieve a CR or PR)

    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 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; Overall Response (OR) = CR + PR.

    Time frame: At the end of 4 cycles of treatment, up to 24 weeks.

07

Results

Posted Oct 21, 2016

Participant flow

Participant flow — Overall Study
MilestoneChemotherapy
Started55
Completed46
Not completed9
Withdrew: Withdrawal by subject4
Withdrew: Ineligible5

Outcome measures

PrimaryOverall Response Rate (Patients That Achieve a CR or PR)

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 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; Overall Response (OR) = CR + PR.

Time frame:
At the end of 4 cycles of treatment, up to 24 weeks.
Reported as:
Number · participants
Overall Response Rate (Patients That Achieve a CR or PR)
participantsChemotherapy
Overall Response Rate (Patients That Achieve a CR or PR)13

Adverse events

Collected over Adverse events were collected from the time of signing the informed consent through 30 days after the final dose of chemotherapy, up to 24 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chemotherapy—3/46 (6.5%)20/46 (43.5%)
Most frequent serious events
Most frequent serious events
EventChemotherapy
PneumoniaInfections and infestations1/46
SepsisInfections and infestations1/46
NeutropeniaInvestigations1/46
acute renal insufficiencyRenal and urinary disorders1/46
HypercalcemiaMetabolism and nutrition disorders1/46
Most frequent other events
Showing 10 of 23
Most frequent other events
EventChemotherapy
ThrombocytopeniaInvestigations7/46
FatigueGeneral disorders6/46
DyspneaRespiratory, thoracic and mediastinal disorders5/46
Pain- NOSMusculoskeletal and connective tissue disorders5/46
AnemiaBlood and lymphatic system disorders4/46
LeukopeniaBlood and lymphatic system disorders3/46
NeutropeniaBlood and lymphatic system disorders2/46
Pleural EffusionRespiratory, thoracic and mediastinal disorders2/46
TachycardiaCardiac disorders2/46
Increased ALTInvestigations1/46

Baseline characteristics

All patients that signed consent and received at least one dose of chemotherapy.

Age, Categorical
Age, Categorical(Participants)Chemotherapy
<=18 years0
Between 18 and 65 years28
>=65 years18
Age, Continuous
Age, Continuous(years)Chemotherapy
Mean60 (48 to 78)
Gender
Gender(Participants)Chemotherapy
Female22
Male24
Region of Enrollment
Region of Enrollment(participants)Chemotherapy
United States46
08

Study locations

2 sites
  • Harborview Medical Center
    Seattle, Washington 98104, United States
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00564733
Lead sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
Responsible party
Keith D Eaton (Principal Investigator, University of Washington) — Principal investigator
First posted
Nov 28, 2007
Start date
Oct 2007
Primary completion
Sep 2011
Completion
Mar 2012
Results posted
Oct 21, 2016
Last update
Feb 10, 2017

Study contacts

Keith Eaton
principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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