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)
18 Years
N/A
Both
Lung Cancer
Trial Information
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)
OBJECTIVES:
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Months from on-study to expired/last date known alive.
Outcome Time Frame:
14.95 months (average duration, on study date to off-study date)
Safety Issue:
No
Principal Investigator
Vicki Keedy, MD
Investigator Role:
Study Director
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
VICC THO 0319
NCT ID:
NCT00664105
Start Date:
February 2004
Completion Date:
June 2008
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Swedish Cancer Institute | Seattle, Washington 98104 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| St. Thomas Health Services | Nashville, Tennessee 37205 |
| Meharry Medical College | Nashville, Tennessee 37208-3599 |
| The West Clinic, PC | Memphis, Tennessee 38120 |
| Erlanger Health System | Chattanooga, Tennessee 37403 |
| Ut Southwestern Medical Center | Dallas, Texas 75390 |
| University Hospital of Cleveland | Cleveland, Ohio 44106 |
| Chesapeake Oncology Hematology Associates | Baltimore, Maryland 21225 |
| University of Tennessee Medical Center | Knoxville, Tennessee 37920 |
| M.D. Anderson Cancer Center, Orlando | Orlando, Florida 32806 |
| Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center | Allentown, Pennsylvania 18103 |
| Clarksville Regional Hematology Oncology Group | Clarksville, Tennessee 37043 |
| Jackson Madison County Hospital | Jackson, Tennessee 38301 |
