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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Total cisplatin dose

Safety Issue:

No

Principal Investigator

Charles M. Rudin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000455112

NCT ID:

NCT00281970

Start Date:

August 2004

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410