NCT00281970CompletedPhase 2
Phase II Trial of Weekly Docetaxel (Taxotere®) and Monthly Cisplatin Chemotherapy as Adjuvant Treatment for Patients With Completely Resected Non-small Cell Lung Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins3 sites in 1 country50 target enrollmentStarted: August 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Total cisplatin dose
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that has been completely removed by surgery.
Detailed Description
OBJECTIVES:
Primary
- Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell lung cancer.
Secondary
- Explore the relationship of time to recurrence, disease-free survival, and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Pathologically proven non-small cell lung cancer (NSCLC)
- •Stage IA-IIIB disease
- •Underwent prior complete surgical resection (R0) no more than 2 months ago
- •Eligible for cisplatin-based adjuvant chemotherapy
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status ≥ 70%
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •Platelet count ≥ 100,000/mm^3
- •Creatinine clearance > 55 mL/min
- •Total bilirubin normal
- •Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria:
- •Alkaline phosphatase (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
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •No peripheral neuropathy > grade 1
- •No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior postoperative radiation therapy
- •No prior chemotherapy for NSCLC
- •No prior docetaxel or cisplatin
- •No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Total cisplatin dose
Secondary Outcomes
- Toxicity
- Overall survival
- Disease-free survival
Investigators
Study Sites (3)
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