Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00664105
Last Updated: 2012-09-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
63 participants
INTERVENTIONAL
2004-02-29
2008-06-30
Brief Summary
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PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.
Detailed Description
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Primary
* To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin.
Secondary
* To determine the overall response rate in patients treated with this regimen.
* To determine the time to disease progression in patients treated with this regimen.
* To assess the safety and tolerability of this regimen in these patients.
OUTLINE:
* This is a Phase II, open label, multi-center study to determine the overall survival rate for patients treated with concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin. Eligible patients will receive concurrent therapy with docetaxel (20 mg/m2) administered weekly for seven weeks as a 30-minute intra-venous (IV) infusion followed by carboplatin (AUC 2) administered weekly for seven weeks as a 30-minute IV infusion. Concurrent radiation therapy will be administered at a dose of 1.8 Gy daily 5 days/week for 25 fractions followed by a dose of 2.0 Gy daily, 5 days/week for 9 fractions (total of 34 fractions). There will be a three-week rest period following the end of the concurrent chemotherapy after which the consolidation phase will begin. During this phase of the study, patients will be treated with docetaxel (75 mg/m2) administered as a 1-hour IV infusion followed by carboplatin (AUC 6) administered as a 30-minute IV infusion. Patient will be treated every three weeks for a total of two cycles.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapeutic Intervention
Carboplatin
Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment.
Docetaxel
Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks).
radiation therapy
Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.
Interventions
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Carboplatin
Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment.
Docetaxel
Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks).
radiation therapy
Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion
* Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC
* Patients must have at least one site of unidirectionally measurable disease
* Patients must be ≥ 3 weeks from a formal exploratory thoracotomy
* Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry
* Patients must be ≥ 18 years of age
* Women of childbearing potential must have a negative baseline serum pregnancy within 7 days prior to Week 1, Day 1 and must not be breast feeding.
* Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.
* Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Hemoglobin \> 9.0 gm/dL
* Creatinine \< 1.5
* Platelets \> 100,000/mm3
* Total bilirubin within normal limits (WNL)
* AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility, as per chart on page 10 of the protocol.
* Calculated CrCl \> 50 ml/min (via Cockroft-Gault formula).
* Forced expiratory volume in 1 second (FEV 1) \> 800 ml
Exclusion Criteria
* Peripheral neuropathy Grade ≥ 2.
* Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC
* Previous chemotherapy or radiation therapy
* Any concomitant malignancy, brain metastasis or uncontrolled, clinically significant medical or psychiatric disorder
* Pregnant or nursing women
* A greater than or equal to 10% weight loss over the past 3 months
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Vicki Keedy, MD
Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Assistant Medical Director, Clinical Trials Shared Resource; Medical Oncologist
Principal Investigators
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Vicki Keedy, MD
Role: STUDY_DIRECTOR
Vanderbilt-Ingram Cancer Center
Locations
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M.D. Anderson Cancer Center, Orlando
Orlando, Florida, United States
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
Allentown, Pennsylvania, United States
Erlanger Health System
Chattanooga, Tennessee, United States
Clarksville Regional Hematology Oncology Group
Clarksville, Tennessee, United States
Jackson Madison County Hospital
Jackson, Tennessee, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
The West Clinic, PC
Memphis, Tennessee, United States
St. Thomas Health Services
Nashville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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VU-VICC-THO-0319
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-030269
Identifier Type: -
Identifier Source: secondary_id
VICC THO 0319
Identifier Type: -
Identifier Source: org_study_id