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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Docetaxel
radiation therapy
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M.D. Anderson Cancer Center, Orlando
  • Chesapeake Oncology Hematology Associates
  • University Hospital of Cleveland
  • Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
  • Erlanger Health System
  • Clarksville Regional Hematology Oncology Group
  • Jackson Madison County Hospital
  • Tennessee Cancer Specialists
  • University of Tennessee Medical Center
  • The West Clinic, PC
  • St. Thomas Health Services
  • Meharry Medical College
  • Vanderbilt-Ingram Cancer Center
  • UT Southwestern Medical Center
  • Swedish Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Intervention

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival
Months from on-study to expired/last date known alive.

Secondary Outcome Measures

Overall Response Rate
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
Time to disease progression in months
Number of Participants With Adverse Events by Grade
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

Full Information

First Posted
April 19, 2008
Last Updated
August 30, 2012
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00664105
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Treatment became standard.
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
None specified
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention 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).
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
none specified
Intervention 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.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Months from on-study to expired/last date known alive.
Time Frame
14.95 months (average duration, on study date to off-study date)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
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 Frame
on-study date to date of best response
Title
Time to Disease Progression
Description
Time to disease progression in months
Time Frame
on-study date to date of progression
Title
Number of Participants With Adverse Events by Grade
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 with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event
Time Frame
30 days after last treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicki Keedy, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Director
Facility Information:
Facility Name
M.D. Anderson Cancer Center, Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Chesapeake Oncology Hematology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
University Hospital of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Clarksville Regional Hematology Oncology Group
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Jackson Madison County Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
The West Clinic, PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
St. Thomas Health Services
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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