Lung Cancer Clinical Trial
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)
Verified date | August 2012 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 63 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) - 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: - 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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center | Allentown | Pennsylvania |
United States | Chesapeake Oncology Hematology Associates | Baltimore | Maryland |
United States | Erlanger Health System | Chattanooga | Tennessee |
United States | Clarksville Regional Hematology Oncology Group | Clarksville | Tennessee |
United States | University Hospital of Cleveland | Cleveland | Ohio |
United States | UT Southwestern Medical Center | Dallas | Texas |
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 | Meharry Medical College | Nashville | Tennessee |
United States | St. Thomas Health Services | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | M.D. Anderson Cancer Center, Orlando | Orlando | Florida |
United States | Swedish Cancer Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Months from on-study to expired/last date known alive. | 14.95 months (average duration, on study date to off-study date) | No |
Secondary | Overall Response Rate | 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 |
on-study date to date of best response | No |
Secondary | Time to Disease Progression | Time to disease progression in months | on-study date to date of progression | No |
Secondary | Number of Participants With Adverse Events by Grade | 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 | 30 days after last treatment. | Yes |
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