Expired Study
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Baltimore, Maryland 21225


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

VICC THO 0319


NCT ID:

NCT00664105


Secondary ID:

VU-VICC-THO-0319


Study Acronym:


Brief Title:

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


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)


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt-Ingram Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

Treatment became standard.


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

68


Enrollment Type:

Actual


Overall Contact Information

Official Name:Vicki Keedy, MD
Study Director
Vanderbilt-Ingram Cancer Center

Study Dates

Start Date:February 2004
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:July 2011
Last Changed Date:July 28, 2011
First Received Date:April 19, 2008
First Results Date:September 30, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Overall Survival
Time Frame:14.95 months (average duration, on study date to off study date)
Safety Issues:False
Description:Months from on study to expired/last date known alive.
Outcome Type:Secondary Outcome
Measure:Patients' Response
Time Frame:Off treatment date.
Safety Issues:False
Description:Patient response to treatment: 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 lesio
Outcome Type:Secondary Outcome
Measure:Time to Disease Progression
Time Frame:Off study date.
Safety Issues:False
Description:Time to disease progression in months
Outcome Type:Secondary Outcome
Measure:Number of Participants With Adverse Events
Time Frame:30 days after last treatment.
Safety Issues:True
Description: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

Study Interventions

Intervention Type:Drug
Name:Carboplatin
Description:Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment.
Arm Name:Therapeutic Intervention
Other Name:None specified
Intervention Type:Drug
Name:Docetaxel
Description:Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks).
Arm Name:Therapeutic Intervention
Other Name:Taxotere
Intervention Type:Radiation
Name:radiation therapy
Description:Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.
Arm Name:Therapeutic Intervention
Other Name:none specified

Study Arms

Study Arm Type:Experimental
Arm Name:Therapeutic Intervention

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt-Ingram Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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