Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)

Stopped early · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00664105

Run by

Vanderbilt-Ingram Cancer Center

People needed

63

Starts

2004-02-01

Expected to finish

2008-06-01

Last updated by the study team

2012-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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

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

Where it is running

• M.D. Anderson Cancer Center, Orlando — Orlando, Florida, United States
• Chesapeake Oncology Hematology Associates — Baltimore, Maryland, United States
• University Hospital of Cleveland — Cleveland, Ohio, United States
• Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center — Allentown, Pennsylvania, United States
• Erlanger Health System — Chattanooga, Tennessee, United States
• Clarksville Regional Hematology Oncology Group — Clarksville, Tennessee, 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
• St. Thomas Health Services — Nashville, Tennessee, United States
• Meharry Medical College — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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