Lung Cancer
Conditions
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES: Primary * Determine the antitumor activity of docetaxel and cisplatin, as measured by tumor response rate, in patients with chemotherapy-naïve stage IIIB or IV non-small cell lung cancer. Secondary * Determine the duration of response in patients treated with this regimen. * Determine time to disease progression in patients treated with this regimen. * Determine the 1-year survival rate in patients treated with this regimen. * Determine the median survival time in patients treated with this regimen. * Correlate aneuploidy (as determined by DNA histograms) and immunohistochemical expression of stathmin, Aurora-A, and survivin with response in patients treated with this regimen. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour once on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 13-19 months.
Interventions
DRUGcisplatin
DRUGdocetaxel
Sponsors
National Cancer Institute (NCI)
Aventis Pharmaceuticals
University of Medicine and Dentistry of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria: * Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following: * Positive cytology * Exudative effusion AND lactic dehydrogenase (LDH) \> 200 IU with effusion/serum LDH ratio ≥ 0.6 * Stage IV disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan * Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * AST and ALT normal * Bilirubin normal Renal * Creatinine clearance ≥ 50 mL/min Immunologic * No known HIV positivity * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No clinically significant active infection Other * Not pregnant or nursing * Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment * No other primary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious systemic disorder that would preclude study participation * No other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal growth factor receptor \[EGFR\]) allowed provided there is disease progression during therapy and patient has recovered * No concurrent immunotherapy * No concurrent prophylactic colony-stimulating factors * No concurrent interleukin-11 Chemotherapy * No prior cytotoxic chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy for the malignancy Radiotherapy * See Disease Characteristics * More than 28 days since prior radiotherapy and recovered * No prior radiotherapy to ≥ 25% of the bone marrow * No prior radiotherapy to sites of measurable disease unless there is documented tumor progression after completion of radiotherapy * No concurrent radiotherapy Surgery * No concurrent surgery for the malignancy Other * More than 3 weeks since prior investigational drugs * Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR) allowed provided there is disease progression during therapy and patient has recovered * No other concurrent investigational or commercial agents or therapies for the malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Tumor Response Rate | 7 years | Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progressive Disease | 8 years | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| 1-year Survival Rate | 1 year | — |
| Median Survival Time | 10 years | — |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the Cancer Institute of New Jersey (a comprehensive cancer center) and 4 affiliate community hospitals part of the Cancer Institute of New Jersey Oncology Group from December 2003 through February 2008.
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel and Cisplatin A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15. | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Docetaxel and Cisplatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 63 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 45 / 49 |
| other Total, other adverse events | 49 / 49 |
| serious Total, serious adverse events | 18 / 49 |
Outcome results
Primary
Overall Tumor Response Rate
Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate.
Time frame: 7 years
Population: Analysis was performed on the first 47 patients. Study was Terminated before 2 of the patients met the pre-specified time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel and Cisplatin | Overall Tumor Response Rate | 21 percentage of participants |
Secondary
1-year Survival Rate
Time frame: 1 year
Population: Analysis was performed on the first 47 patients . Study was Terminated before 2 of the patients met the pre-specified time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel and Cisplatin | 1-year Survival Rate | 38 percentage of participants |
Secondary
Median Survival Time
Time frame: 10 years
Population: Analysis was performed on the first 47 patients. Study was Terminated before 2 of the patients met the pre-specified time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Docetaxel and Cisplatin | Median Survival Time | 9.1 months |
Secondary
Time to Progressive Disease
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 8 years
Population: Analysis was performed on the first 47 patients . Study was Terminated before 2 of the patients met the pre-specified time point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Docetaxel and Cisplatin | Time to Progressive Disease | 3.38 months |