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

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: docetaxel; Procedure: adjuvant therapy; Drug: cisplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00281970

JHOC-J0435

P30CA006973 (U.S. NIH Grant/Contract)

20040761 (Other Identifier)

MSKCC-04039

J0435

CDR0000455112 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 8 hours on day 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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