Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-D-2934 | Other Identifier | Barbara Ann Karmanos Cancer Institute | |
| WSU-0507002542 | Other Identifier | Wayne State University - Human Investigation Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as cisplatin, pemetrexed disodium, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one chemotherapy drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and pemetrexed disodium together with radiation therapy followed by docetaxel works in treating patients with stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over 60 minute on day 1. Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity. Patients also receive concurrent thoracic radiotherapy in weeks 1-7. Between 3-8 weeks after completion of chemoradiotherapy, patients with no progressive disease receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for 3 courses.
After completion of study therapy, patients are followed at 1 month and periodically thereafter.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin, Docetaxel & Radiation Therapy | Experimental | Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Overall Survival at One Year | Overall Survival at one year using Kaplan-Meier product-limit analysis | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival using Kaplan-Meier estimates | Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later. |
| Overall Survival |
Not provided
DISEASE CHARACTERISTICS:
Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
Stage IIIA disease, meeting all of the following criteria:
Mediastinal lymph node involvement
Paralyzed left vocal cord with separate lung primary distinct from the aorto-pulmonary lymph nodes on the CT scan
Stage IIIB disease, meeting all of the following criteria:
N3 lymph node involvement
Enlarged N3 lymph nodes on CT scan confirmed by PET scan
Right-sided primary tumor with left vocal cord paralysis
Evidence of tumor extension into the mediastinum and/or mediastinal structures by mediastinoscopy, bronchoscopy, or CT scan
No evidence of malignant pleural effusion unless effusion is only evident on CT scan
No more than 1 parenchymal lesions on the same or opposite sides of the lung
No brain metastases by CT scan or MRI
PATIENT CHARACTERISTICS:
SWOG performance status 0 or 1
Platelet count ≥ 100,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Creatinine clearance ≥ 45 mL/min
Bilirubin normal
Transaminases (SGOT and/or SGPT) ≤ 1.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Total lung volume (i.e., right and left lung minus the gross tumor volume) receiving greater than 20 Gy of radiation ≤ 40%
FEV_1 ≥ 70% of predicted
DLCO ≥ 50 mL/min
No other concurrent malignancy
No peripheral neuropathy ≥ grade 2
No serious medical illness, including, but not limited to, any of the following:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Must be willing and able to take folic acid, cyanocobalamin (vitamin B12), or dexamethasone
PRIOR CONCURRENT THERAPY:
No prior chemotherapy or radiotherapy for NSCLC
No concurrent participation in another therapeutic investigational study
Concurrent ibuprofen (400 mg four times daily) allowed during pemetrexed disodium administration provided the patient has normal renal function
No concurrent aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) 2 days before, during, and for 2 days after pemetrexed disodium administration
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States | ||
| Veterans Affairs Medical Center - Detroit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21415776 | Derived | Gadgeel SM, Ruckdeschel JC, Patel BB, Wozniak A, Konski A, Valdivieso M, Hackstock D, Chen W, Belzer K, Burger AM, Marquette L, Turrisi A. Phase II study of pemetrexed and cisplatin, with chest radiotherapy followed by docetaxel in patients with stage III non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):927-33. doi: 10.1097/JTO.0b013e3182156109. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin, Docetaxel & Radiation Therapy | Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43 Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43 Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Docetaxel | Drug | Docetaxel 75 mg/m2 on day 1 of each cycle |
|
|
| Pemetrexed disodium | Drug | Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43 |
|
|
| Radiation therapy | Radiation | Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. |
|
Overall survival using Kaplan-Meier estimates
| Date of registration to the date of death |
| Safety Outcomes | Toxicity: total number of SAEs and other AEs | 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year |
| Detroit |
| Michigan |
| 48201 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin, Docetaxel & Radiation Therapy | Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43 Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43 Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Probability of Overall Survival at One Year | Overall Survival at one year using Kaplan-Meier product-limit analysis | Posted | Number | 95% Confidence Interval | probability of overall survival at 1 yr. | at 1 year |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival using Kaplan-Meier estimates | Posted | Median | 95% Confidence Interval | months | Approximately 3 weeks after the last cycle of cisplatin/pemetrexed or completion of radiation whichever is the later. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival using Kaplan-Meier estimates | Posted | Median | 95% Confidence Interval | months | Date of registration to the date of death |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety Outcomes | Toxicity: total number of SAEs and other AEs | Posted | Number | Adverse event | 72 hours after 2nd and 3rd cycles: 30 days after completion of study treatment; Every 2 months thereafter; then once a year |
|
|
Approximately 7 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisplatin, Docetaxel & Radiation Therapy | Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43 Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43 Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy. | 15 | 29 | 29 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary exacerbation | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Decreased WBC count | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alanine Aminotransferase (ALT) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Study being a single institution, single arm study.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shrish Gadgeel, M.D. | Barbara Ann Karmanos Cancer Institute | (313) 556-8820 | sgadgee1@hfhs.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D000068437 | Pemetrexed |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D013812 | Therapeutics |
Not provided
Not provided
| >=65 years |
|
|
|
|