Trial Outcomes & Findings for FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer (NCT NCT00564733)

Last Updated: 2017-02-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

55 participants

Primary outcome timeframe

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

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy 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 that are responding to treatment 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.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. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies
Overall Study STARTED	55
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy 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 that are responding to treatment 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.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. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies
Overall Study Withdrawal by Subject	4
Overall Study Ineligible	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy n=46 Participants 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 that are responding to treatment 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.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. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Gender Female	22 Participants n=5 Participants
Gender Male	24 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

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

Population: All patients that signed consent and received at least one cycle of chemotherapy.

Outcome measures

Outcome measures
Measure	Chemotherapy n=46 Participants 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 that are responding to treatment 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.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. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies
Overall Response Rate (Patients That Achieve a CR or PR)	13 participants

Adverse Events

Chemotherapy

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy n=46 participants at risk 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 that are responding to treatment 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.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. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies
Infections and infestations Pneumonia	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Infections and infestations Sepsis	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Investigations Neutropenia	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Renal and urinary disorders acute renal insufficiency	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Metabolism and nutrition disorders Hypercalcemia	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.

Other adverse events

Other adverse events
Measure	Chemotherapy n=46 participants at risk 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 that are responding to treatment 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.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. carboplatin: Given IV docetaxel: Given IV gemcitabine hydrochloride: Given IV paclitaxel: Given IV computed tomography: Undergo FDG PET/CT positron emission tomography: Undergo FDG PET/CT fludeoxyglucose F 18: Given IV imaging biomarker analysis: Correlative studies
Investigations Increased ALT	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Blood and lymphatic system disorders Anemia	8.7% 4/46 • Number of events 5 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Vascular disorders Thromboembolic Event	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Metabolism and nutrition disorders Dehydration	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.9% 5/46 • Number of events 5 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
General disorders Fatigue	13.0% 6/46 • Number of events 6 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
General disorders Fever	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Metabolism and nutrition disorders Hypercalcemia	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Metabolism and nutrition disorders Hypoalbuminemia	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Psychiatric disorders Anxiety	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Blood and lymphatic system disorders Leukopenia	6.5% 3/46 • Number of events 4 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Investigations Lymphocyte count decreased	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Gastrointestinal disorders Nausea	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Blood and lymphatic system disorders Neutropenia	4.3% 2/46 • Number of events 3 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Musculoskeletal and connective tissue disorders Pain- NOS	10.9% 5/46 • Number of events 5 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.3% 2/46 • Number of events 2 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Infections and infestations Pneumonia	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Nervous system disorders Syncope	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Cardiac disorders Tachycardia	4.3% 2/46 • Number of events 2 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Investigations Thrombocytopenia	15.2% 7/46 • Number of events 8 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.
Gastrointestinal disorders Vomiting	2.2% 1/46 • Number of events 1 • 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. Only grade 3 and higher adverse events or adverse events that led to a dose reduction or dose delay were captured. Hospitalizations related to disease progression were not captured as serious adverse events.

Additional Information

Keith D. Eaton, MD, PhD

University of Washington

Phone: 2062886249

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place