FDG-PET in Helping Doctors Plan Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00564733

Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, gemcitabine, 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 procedures, such as fludeoxyglucose F 18 (FDG) positron emission tomography (PET) scan and CT scan, may help doctors plan chemotherapy for patients with non-small cell lung cancer.

PURPOSE: This phase II trial is studying how well FDG-PET works in helping doctors plan chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: docetaxel Drug: fludeoxyglucose F 18 Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: computed tomography Procedure: imaging biomarker analysis Procedure: positron emission tomography	Phase II

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans

Drug Information available for: Carboplatin Docetaxel Gemcitabine hydrochloride Gemcitabine Paclitaxel Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate in initial non-responders [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ability of fludeoxyglucose F 18 (FDG) positron emission tomography to predict response to therapy as measured by CT scan [ Designated as safety issue: No ]
The early and late changes in tumor FDG uptake and correlation with overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	October 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Assess the response rate in patients with stage IIIB or IV non-small cell lung cancer who do not demonstrate an early response to carboplatin and paclitaxel as determined by fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) ("initial non-responders") who are subsequently treated with three additional courses of docetaxel and gemcitabine hydrochloride.

Secondary

Evaluate the ability of FDG-PET to predict response to therapy as measured by CT scan.
Evaluate the early and late changes in tumor FDG uptake in all patients and correlate with overall survival (OS).

OUTLINE: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients then undergo fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) and CT scan on day 18. Subsequent therapy is based on FDG-PET response. Patients determined to be PET responders* (i.e., a decrease in maximum standardized uptake value [SUV] of > 20%), continue treatment with paclitaxel and carboplatin. Treatment repeats every 3 weeks for 3 additional courses.

NOTE: *Patients with a metabolic response [FDG-PET responders] but clearly progresses by CT RECIST criteria as determined by two independent images are switched to the alternate docetaxel and gemcitabine hydrochloride chemotherapy.

Patients determined to be PET non-responders** receive an alternate chemotherapy regimen. Beginning with course 2 (day 22), patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment with gemcitabine hydrochloride and docetaxel repeats every 3 weeks for 3 courses. Patients undergo FDG-PET and CT scan on day 39 of course 2 to assess response to the alternate chemotherapy. After the initiation of course 2, patients who progress by CT RECIST criteria are removed from study.

NOTE: **Patients whose primary tumor demonstrates a partial response by CT RECIST (limited to the target lesion) and is a non-responder by FDG-PET are continued on the initial paclitaxel and carboplatin chemotherapy.

Approximately 3 weeks after completion of chemotherapy (day 81-84), all patients undergo another FDG-PET and CT scan. After completion of study therapy, patients are followed periodically.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
- Stage IIIB with malignant pleural effusion or with nodal disease so extensive that it is not amenable to radiotherapy with curative intent
- Stage IV disease
Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (≥ 10 mm with spiral CT scan)
Baseline fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) scan must demonstrate a target lesion with standardized uptake value (SUV) ≥ 2 times background and SUV > 3
- Baseline FDG-PET and CT scans performed within two weeks from the start of chemotherapy
No post-obstructive pneumonia or lobar collapse

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 3 months
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST/ALT ≤ 2 times ULN (< 5 times ULN for patients with liver metastases)
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 40 mL/min
Weight < 400 lbs
Not pregnant or nursing
Fertile patients must use effective contraception during chemotherapy and for 30 days after the last dose of chemotherapy
Able and willing to take premedication corticosteroids required for the chemotherapies in this trial
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study
No diabetes requiring insulin for management
No significant neuropathy (CTC grade > 2)
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
No detectable second malignancy

PRIOR CONCURRENT THERAPY:

No palliative radiation therapy for painful bony metastases, impending fractures, or hemoptysis
Prior radiotherapy allowed provided patient has recovered from the side effects of therapy (except alopecia) and measurable disease (target lesion) is present outside of the radiation field
More than 1 week since prior EGFR tyrosine kinase inhibitors (i.e., erlotinib or gefitinib)
No prior conventional chemotherapy for NSCLC
No concurrent routine use of colony stimulating factors during treatment with carboplatin/paclitaxel
No other concurrent investigational agents
No other concurrent anticancer therapy, immunotherapy, hormonal cancer therapy, curative radiation therapy, or palliative radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564733

Locations

United States, Washington
Fred Hutchinson Cancer Research Center	Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Kari L. Stricker 206-667-5621
Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104
Contact: Hannah M. Linden, MD 206-731-3000
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Keith Eaton, MD, PhD

Fred Hutchinson Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Seattle Cancer Care Alliance ( Keith Eaton )
Study ID Numbers:	CDR0000577414, UWCC-6566, UWCC-UW-6566, UWCC-07-8678-H/A
Study First Received:	November 27, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00564733
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors

Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009