Back to resultsPh II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Inclusion criteria: Histologically confirmed non-small cell lung cancer Stage I-IIIA disease Must have undergone a complete resection Must begin adjuvant chemotherapy within 8 weeks of surgical resection PATIENT CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 100,000/mm^3 Serum creatinine normal OR creatinine clearance ≥ 40 mL/min Bilirubin normal Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria: AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN) AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN AP ≤ 5 times ULN AND AST and ALT normal Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study therapy Exclusion criteria: Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded. Women who are currently or planning to breast feed. Those with peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: 2-8 weeks since prior surgery and recovered
Sites / Locations
- University of North Carolina Lineberger Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm Trial
Arm Description
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
Outcomes
Primary Outcome Measures
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
Secondary Outcome Measures
Patterns of Recurrence in Patients Treated With This Regimen
Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.
Toxicity in Patients Treated With This Regimen
Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).
Progression Free Survival
Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.
Overall Survival
Overall survival rate at 18 months.
Full Information
NCT ID
NCT00280735
First Posted
January 19, 2006
Last Updated
June 9, 2017
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Aventis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00280735
Brief Title
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
Official Title
Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2004 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Aventis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES:
Primary
Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.
Secondary
Determine the toxicity of this regimen in these patients.
Determine the survival patterns of patients treated with this regimen.
Assess the patterns of recurrence in patients treated with this regimen.
OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA 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
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm Trial
Arm Type
Other
Arm Description
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
paraplatin
Intervention Description
Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75 mg/m² intravenously, once, every 3 weeks
Primary Outcome Measure Information:
Title
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
Description
Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
Time Frame
12 weeks from initiating adjuvant therapy
Secondary Outcome Measure Information:
Title
Patterns of Recurrence in Patients Treated With This Regimen
Description
Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.
Time Frame
Up to 5 years
Title
Toxicity in Patients Treated With This Regimen
Description
Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).
Time Frame
Day 1 of treatment to 30 days after treatment discontinuation
Title
Progression Free Survival
Description
Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.
Time Frame
The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
Title
Overall Survival
Description
Overall survival rate at 18 months.
Time Frame
The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed non-small cell lung cancer
Stage I-IIIA disease
Must have undergone a complete resection
Must begin adjuvant chemotherapy within 8 weeks of surgical resection
PATIENT CHARACTERISTICS:
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Hemoglobin ≥ 8.0 g/dL
Platelet count ≥ 100,000/mm^3
Serum creatinine normal OR creatinine clearance ≥ 40 mL/min
Bilirubin normal
Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria:
AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
AP ≤ 5 times ULN AND AST and ALT normal
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study therapy
Exclusion criteria:
Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded.
Women who are currently or planning to breast feed.
Those with peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
2-8 weeks since prior surgery and recovered
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A. Socinski, MD
Organizational Affiliation
Florida Hospital Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18303435
Citation
Stinchcombe TE, Harper HD, Hensing TA, Moore DT, Crane JM, Atkins JN, Willard EM, Detterbeck FC, Socinski MA. The feasibility of adjuvant carboplatin and docetaxel in patients with curatively resected non-small cell lung cancer. J Thorac Oncol. 2008 Feb;3(2):145-51. doi: 10.1097/JTO.0b013e318160c5f1.
Results Reference
result
Links:
URL
http://unclineberger.org
Description
UNC Lineberger Comprehensive Cancer Center
Learn more about this trial
Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
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