Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Single Arm Trial
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: carboplatin (Drug)
Single Arm Trial
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: docetaxel (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
Time Frame: 12 weeks from initiating adjuvant therapy
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 Outcomes
- Patterns of Recurrence in Patients Treated With This Regimen(Up to 5 years)
- Toxicity in Patients Treated With This Regimen(Day 1 of treatment to 30 days after treatment discontinuation)
- Overall Survival(The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months)
- Progression Free Survival(The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months)