Status:
TERMINATED
Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
OBJECTIVES: Primary * To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00664105
Start Date
February 1 2004
End Date
June 1 2008
Last Update
September 7 2012
Active Locations (15)
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1
M.D. Anderson Cancer Center, Orlando
Orlando, Florida, United States, 32806
2
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, United States, 21225
3
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
4
Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
Allentown, Pennsylvania, United States, 18103