Lung Cancer
Conditions
Keywords
squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.
Detailed description
OBJECTIVES: * Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT. * Compare the toxicity of these regimens in these patients. * Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens. * Determine the feasibility of delivering 3-D XRT to patients in this multicenter study. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses. * Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses. In both arms, treatment continues in the absence of disease progression. Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.
Interventions
DRUGcarboplatin
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
DRUGgemcitabine hydrochloride
1000 mg/sq m IV over 30 min days 1 & 8 repeat q 21 days for 2 cycles; then 35 mg/sq m IV over 30 min 2X wk for 7 wks
DRUGpaclitaxel
225 mg/sq m IV over 3 hrs q 21 days for 2 cycles, then 45 mg/sq m IV over 1 hr q wk for 7 wks
RADIATIONradiation therapy
3-D XRT 7400 cGy total after induction (during cycles 3-9)
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Squamous cell carcinoma * Adenocarcinoma, including bronchoalveolar cell carcinoma * Large cell anaplastic carcinoma, including giant and clear cell carcinoma * Inoperable stage IIIA or IIIB disease * No direct invasion of vertebral body * Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field * Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field * No scalene, supraclavicular, or contralateral hilar node involvement * Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field * No exudative, bloody, or cytologically malignant pleural effusion * Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * The following are not considered measurable disease: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions in a previously irradiated field PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin less than 1.5 mg/dL * AST less than 2 times upper limit of normal Renal: * Creatinine clearance 20-130 mL/min for females * Creatinine clearance 20-150 mL/min for males Pulmonary: * FEV1 at least 1.2 L Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for NSCLC * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics Radiotherapy: * See Disease Characteristics * No prior radiotherapy for NSCLC Surgery: * At least 2 weeks since prior exploratory thoracotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response | 18 months post treatment | Response is assessed as failure free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 6 years post treatment | — |
| Toxicity | 13 weeks | Toxicity will be assessed during treatment |
Countries
United States
Outcome results
None listed