Study Stopped
Treatment became standard.
Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
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)
3 other identifiers
interventional
63
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lung-cancer
Started Feb 2004
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 19, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
March 22, 2011
CompletedSeptember 7, 2012
August 1, 2012
4.3 years
April 19, 2008
September 30, 2010
August 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Months from on-study to expired/last date known alive.
14.95 months (average duration, on study date to off-study date)
Secondary Outcomes (3)
Overall Response Rate
on-study date to date of best response
Time to Disease Progression
on-study date to date of progression
Number of Participants With Adverse Events by Grade
30 days after last treatment.
Study Arms (1)
Therapeutic Intervention
EXPERIMENTALInterventions
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 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).
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.
Eligibility Criteria
You may qualify if:
- Patients must voluntarily sign and date an informed consent before the initiation of any study procedures
- 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)
- +3 more criteria
You may not qualify if:
- Known hypersensitivity to drugs formulated with polysorbate 80
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (15)
M.D. Anderson Cancer Center, Orlando
Orlando, Florida, 32806, United States
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, 21225, United States
University Hospital of Cleveland
Cleveland, Ohio, 44106, United States
Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
Allentown, Pennsylvania, 18103, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
Clarksville Regional Hematology Oncology Group
Clarksville, Tennessee, 37043, United States
Jackson Madison County Hospital
Jackson, Tennessee, 38301, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
The West Clinic, PC
Memphis, Tennessee, 38120, United States
St. Thomas Health Services
Nashville, Tennessee, 37205, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Outcome measure #4, "Number of participants with AEs by grade", will not match the total number of participants in this study. Some participants have multiple events in one or more grade designations or some participants have no events at all.
Results Point of Contact
- Title
- Vicki Keedy, M.D.
- Organization
- Vanderbilt-Ingram Cancer Center
Study Officials
- STUDY DIRECTOR
Vicki Keedy, MD
Vanderbilt-Ingram Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Assistant Medical Director, Clinical Trials Shared Resource; Medical Oncologist
Study Record Dates
First Submitted
April 19, 2008
First Posted
April 22, 2008
Study Start
February 1, 2004
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
September 7, 2012
Results First Posted
March 22, 2011
Record last verified: 2012-08