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A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st dose cohort 15mg/m2 taxol plus RT | Experimental | 15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible |
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| 2nd dose cohort20 mg/m2 taxol plus daily RT | Experimental |
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| 3rd Dose Cohort --25mg/m2 taxol plus RT | Experimental |
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| Phase II Arm --20mg/m2 taxol plus RT | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. |
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| Measure | Description | Time Frame |
|---|---|---|
| Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median Survival | This is median survival for all subjects enrolled. | 86 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuhchyau Chen, MD, Ph.D | Universtiy of Rochester, Dept of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester, Dept. Radiation Oncology | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12631594 | Result | Chen Y, Pandya K, Keng PC, Johnstone D, Li J, Lee YJ, Smudzin T, Okunieff P. Phase I/II clinical study of pulsed paclitaxel radiosensitization for thoracic malignancy: a therapeutic approach on the basis of preclinical research of human cancer cell lines. Clin Cancer Res. 2003 Mar;9(3):969-75. |
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| ID | Title | Description |
|---|---|---|
| FG000 | First Dose Cohort (15mg/m2 Taxol) MWF and Daily RT | On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given. A minimum of three patients will be assigned at each dose level. If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group. If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled. Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT |
| FG001 | Second Dose Cohort (20mg/m2 Taxol) MWF and Daily RT | On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given. A minimum of three patients will be assigned at each dose level. If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group. If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled. Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT |
| FG002 | Third Dose Cohort (25mg/m2 Taxol) MWF and Daily RT | A minimum of three patients will be assigned at each dose level. If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group. If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled. Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT |
| FG003 | Phase II Group (20mg/m2 Taxol) | Once the MTD has been determined and confirmed with a total of six patients, up to 19 additional patients with measurable disease will be enrolled at that dose in order to obtain estimates of response rate and more information about toxicity Phase II enrollment will be in two stages. Initially 9 or 12 patients (depending on how many were tested at the MTD dose in the Phase I study) will be tested, for a total of 15 patients at the MTD. If fewer than 4 responses are observed, the study will end with 90% confidence that the true response rate is no greater than 40%, which is the minimum clinically interesting response rate. If four or more responses are observed, additional patients will be enrolled to obtain 25 evaluable patients at the MTD. This will allow estimation of the true response rate and toxicity rates with standard errors of no more than 0.1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily RT Plus Chemo on MWF | Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. | Posted | Number | Percentage subj w dose limiting toxicity | 5 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects Enrolled |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | NCI CTCAE v.4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuhchyau Chen MD, PhD | University of Rochester | 585-275-5575 | yuhchyau_chen@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Radiation Therapy | Procedure | Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible |
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| Death |
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| Cancer progression |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | 3rd Dose Cohort --25mg/m2 Taxol Plus RT | Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible |
|
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| Secondary | Median Survival | This is median survival for all subjects enrolled. | Posted | Median | Full Range | months | 86 months |
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| 7 |
| 41 |
| 3 |
| 18 |
| Adult Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | NCI CTCAE v.4 | Systematic Assessment | community acquired pneumonia |
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| Thromboembolic event | Vascular disorders | NCI CTCAE v.4 | Systematic Assessment | pulmonary embolism |
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| bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v.4 | Systematic Assessment |
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| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI CTCAE v.4 | Systematic Assessment | Pathology showed this to be unrelated to the chemotherapy |
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| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |