Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC

UNC Lineberger Comprehensive Cancer Center75 enrolled

Overview

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

carboplatinDRUG

Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)

docetaxelDRUG

75 mg/m² intravenously, once, every 3 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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: * Eastern Cooperative Oncology Group (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), Aspartate aminotransferase (AST), and Alanine transaminase (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 Exclusion criteria: * Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded. * Women who are currently or planning to breast feed. * Those with peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: * 2-8 weeks since prior surgery and recovered

Locations (1)

University of North Carolina Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen

Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.

Time frame: 12 weeks from initiating adjuvant therapy

Secondary Outcomes

Patterns of Recurrence in Patients Treated With This Regimen

Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.

Time frame: Up to 5 years

Toxicity in Patients Treated With This Regimen

Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).

Time frame: Day 1 of treatment to 30 days after treatment discontinuation

Progression Free Survival

Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.

Time frame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months

Overall Survival

Overall survival rate at 18 months.

Time frame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months

Data from ClinicalTrials.gov

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