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FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Pleural Effusion, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Description:

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Outcome Time Frame:

At the end of 4 courses of treatment

Safety Issue:

No

Principal Investigator

Keith Eaton

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Federal Government

Study ID:

6566

NCT ID:

NCT00564733

Start Date:

October 2007

Completion Date:

March 2012

Related Keywords:

  • Malignant Pleural Effusion
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion
  • Pleural Effusion, Malignant

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Harborview Medical CenterSeattle, Washington  98104