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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281970
• Other study ID #: J0435
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: Phase 2
• Start date: August 2004
• Est. completion date: June 2009

Study information

• Verified date: October 2016
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• docetaxel

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cisplatin dose
Secondary	Toxicity
Secondary	Overall survival
Secondary	Disease-free survival