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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Completed

CT.gov ID

NCT00281970

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

16.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: cisplatin Drug: docetaxel Procedure: adjuvant therapy	Phase 2

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Weekly Docetaxel (Taxotere®) and Monthly Cisplatin Chemotherapy as Adjuvant Treatment for Patients With Completely Resected Non-small Cell Lung Cancer

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2009

Outcome Measures

Primary Outcome Measures

Total cisplatin dose []

Secondary Outcome Measures

Toxicity []
Overall survival []
Disease-free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
2	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
3	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6307