Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT00664105|
Recruitment Status : Terminated (Treatment became standard.)
First Posted : April 22, 2008
Results First Posted : March 22, 2011
Last Update Posted : September 7, 2012
RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy.
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Carboplatin Drug: Docetaxel Radiation: radiation therapy||Phase 2|
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PhII Study of Concurrent Chemoradiotherapy With Weekly Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel and Carboplatin for Locally Advanced Inoperable Non-small Cell Lung Cancer (NSCLC)|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
|Experimental: Therapeutic Intervention||
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.
Other Name: None specifiedDrug: 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).
Other Name: TaxotereRadiation: 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 Name: none specified
- Overall Survival [ Time Frame: 14.95 months (average duration, on study date to off-study date) ]Months from on-study to expired/last date known alive.
- Overall Response Rate [ Time Frame: on-study date to date of best response ]
Patient response to treatment per RECIST:
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
- Time to Disease Progression [ Time Frame: on-study date to date of progression ]Time to disease progression in months
- Number of Participants With Adverse Events by Grade [ Time Frame: 30 days after last treatment. ]Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664105
|United States, Florida|
|M.D. Anderson Cancer Center, Orlando|
|Orlando, Florida, United States, 32806|
|United States, Maryland|
|Chesapeake Oncology Hematology Associates|
|Baltimore, Maryland, United States, 21225|
|United States, Ohio|
|University Hospital of Cleveland|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center|
|Allentown, Pennsylvania, United States, 18103|
|United States, Tennessee|
|Erlanger Health System|
|Chattanooga, Tennessee, United States, 37403|
|Clarksville Regional Hematology Oncology Group|
|Clarksville, Tennessee, United States, 37043|
|Jackson Madison County Hospital|
|Jackson, Tennessee, United States, 38301|
|Tennessee Cancer Specialists|
|Knoxville, Tennessee, United States, 37920|
|University of Tennessee Medical Center|
|Knoxville, Tennessee, United States, 37920|
|The West Clinic, PC|
|Memphis, Tennessee, United States, 38120|
|St. Thomas Health Services|
|Nashville, Tennessee, United States, 37205|
|Meharry Medical College|
|Nashville, Tennessee, United States, 37208|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, Washington|
|Swedish Cancer Institute|
|Seattle, Washington, United States, 98104|
|Study Director:||Vicki Keedy, MD||Vanderbilt-Ingram Cancer Center|