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 - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00281970

Purpose

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	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: docetaxel Procedure: adjuvant therapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Total cisplatin dose [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Overall survival [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281970

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Charles M. Rudin, MD, PhD

Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Azzoli CG, Krug LM, Miller VA, Rizvi NA, Kris MG, Dunne M, Farmer A, Pizzo B, Tyson L, Seeger T, Coleman B, Moore E, Lastinger L, Venkatraman E, Rudin CM. A phase II tolerability study of cisplatin plus docetaxel as adjuvant chemotherapy for resected non-small cell lung cancer. J Thorac Oncol. 2007 Jul;2(7):638-44.

Study ID Numbers:	CDR0000455112, JHOC-J0435, JHOC-WIRB-20040761, MSKCC-04039
Study First Received:	January 24, 2006
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00281970
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009