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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: carboplatin; Drug: docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00280735

LCCC 0320

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Single Arm Trial

Other group

Description:

adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles

Treatment:

Drug: docetaxel

Drug: carboplatin