Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Docetaxel

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