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
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.
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 →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.
Exclusion Criteria:
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
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: RP 56976, Taxotere, TXT
Given IV
Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Given IV
Also known as: Anzatax, Asotax, TAX, Taxol
Undergo FDG PET/CT
Also known as: tomography, computed
Undergo FDG PET/CT
Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Given IV
Also known as: 18FDG, FDG
Correlative studies
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.
| Milestone | Chemotherapy |
|---|---|
| Started | 55 |
| Completed | 46 |
| Not completed | 9 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Ineligible | 5 |
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.
| participants | Chemotherapy |
|---|---|
| Overall Response Rate (Patients That Achieve a CR or PR) | 13 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemotherapy | — | 3/46 (6.5%) | 20/46 (43.5%) |
| Event | Chemotherapy |
|---|---|
| PneumoniaInfections and infestations | 1/46 |
| SepsisInfections and infestations | 1/46 |
| NeutropeniaInvestigations | 1/46 |
| acute renal insufficiencyRenal and urinary disorders | 1/46 |
| HypercalcemiaMetabolism and nutrition disorders | 1/46 |
| Event | Chemotherapy |
|---|---|
| ThrombocytopeniaInvestigations | 7/46 |
| FatigueGeneral disorders | 6/46 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 5/46 |
| Pain- NOSMusculoskeletal and connective tissue disorders | 5/46 |
| AnemiaBlood and lymphatic system disorders | 4/46 |
| LeukopeniaBlood and lymphatic system disorders | 3/46 |
| NeutropeniaBlood and lymphatic system disorders | 2/46 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 2/46 |
| TachycardiaCardiac disorders | 2/46 |
| Increased ALTInvestigations | 1/46 |
All patients that signed consent and received at least one dose of chemotherapy.
| Age, Categorical(Participants) | Chemotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 18 |
| Age, Continuous(years) | Chemotherapy |
|---|---|
| Mean | 60 (48 to 78) |
| Gender(Participants) | Chemotherapy |
|---|---|
| Female | 22 |
| Male | 24 |
| Region of Enrollment(participants) | Chemotherapy |
|---|---|
| United States | 46 |
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