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

Phase 2

Terminated

Conditions: Lung Cancer

Interventions: Drug: Carboplatin
Drug: Docetaxel
Radiation: radiation therapy

Registration Number: NCT00664105

Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

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 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 63

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapeutic Intervention	radiation therapy	-
Therapeutic Intervention	Carboplatin	-
Therapeutic Intervention	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	14.95 months (average duration, on study date to off-study date)	Months from on-study to expired/last date known alive.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	on-study date to date of best response	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
Time to Disease Progression	on-study date to date of progression	Time to disease progression in months
Number of Participants With Adverse Events by Grade	30 days after last treatment.	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

Trial Locations

Locations (15): Erlanger Health System
🇺🇸
Chattanooga, Tennessee, United States
Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
🇺🇸
Allentown, Pennsylvania, United States
The West Clinic, PC
🇺🇸
Memphis, Tennessee, United States
Clarksville Regional Hematology Oncology Group
🇺🇸
Clarksville, Tennessee, United States
Meharry Medical College
🇺🇸
Nashville, Tennessee, United States
Chesapeake Oncology Hematology Associates
🇺🇸
Baltimore, Maryland, United States
University Hospital of Cleveland
🇺🇸
Cleveland, Ohio, United States
St. Thomas Health Services
🇺🇸
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸
Nashville, Tennessee, United States
Swedish Cancer Institute
🇺🇸
Seattle, Washington, United States
M.D. Anderson Cancer Center, Orlando
🇺🇸
Orlando, Florida, 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
UT Southwestern Medical Center
🇺🇸
Dallas, Texas, United States