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Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with
resected stage I, II, or IIIA non-small cell lung cancer.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the survival patterns of patients treated with this regimen.

- Assess the patterns of recurrence in patients treated with this regimen.

OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment
repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Inclusion criteria:

- Histologically confirmed non-small cell lung cancer

- Stage I-IIIA disease

- Must have undergone a complete resection

- Must begin adjuvant chemotherapy within 8 weeks of surgical resection

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Platelet count ≥ 100,000/mm^3

- Serum creatinine normal OR creatinine clearance ≥ 40 mL/min

- Bilirubin normal

- Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

- 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

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study therapy

- No breastfeeding

- No peripheral neuropathy ≥ grade 2

- No history of severe hypersensitivity to docetaxel or polysorbate 80

- Prior history of malignancy allowed provided the attending medical oncologists
believes that adjuvant chemotherapy is indicated and will potentially benefit the
patient

PRIOR CONCURRENT THERAPY:

- 2-8 weeks since prior surgery and recovered

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of administering of carboplatin/docetaxel as adjuvant therapy in resected stage I-IIIA NSCLC

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Mark A. Socinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC 0320

NCT ID:

NCT00280735

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage III non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of North Carolina Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina  27599