Carboplatin and Docetaxel After Surgery in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | May 2004 |
Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
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.
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.
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.
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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
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