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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Plus Carboplatin and Paclitaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer  Monoclonal Antibody Plus Carboplatin and Paclitaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
Monoclonal Antibody Plus Carboplatin and Paclitaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomizedphase II trial to study the effectiveness of combining a monoclonal antibody with carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer.
Details: OBJECTIVES: Part 1 - Determine the safety of monoclonal antibody ABX-EGF (MOAB ABX-EGF) administered with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer. - Determine the pharmacokinetics of this regimen in these patients. - Determine the clinical response in patients treated with this regimen. Part 2 - Compare time to disease progression in patients treated with carboplatin and paclitaxel with vs without MOAB ABX-EGF. - Compare the clinical efficacy of these regimens in these patients. - Compare the safety of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is an open-label, multicenter, dose-escalation study of monoclonal antibody ABX-EGF (MOAB ABX-EGF) followed by a randomized study. - Patients receive MOAB ABX-EGF IV over 1 hour once weekly for 6 weeks. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once on weeks 0 and 3. Cohorts of 5-10 patients receive escalating doses of MOAB ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 5 or 4 of 10 patients experience dose-limiting toxicity. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel and carboplatin as in part 1. - Arm II: Patients receive paclitaxel and carboplatin as in part I and MOAB ABX-EGF as in part 1 at the MTD. At 6 weeks, patients with an objective response (partial or complete response) or stable disease may receive extended therapy comprising paclitaxel and carboplatin once every 3 weeks and MOAB ABX-EGF weekly as above. Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 6, 12, 18, 24, 30, 36, and 42. Patients are followed within 4 weeks and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 240-255 patients (15-30 for part 1 and 225 for part 2 [75 for arm I and 150 for arm II]) will be accrued for this study within 9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria: - Stage IIIB with pericardial or pleural effusion - Stage IV - Epidermal growth factor receptor overexpression by immunohistochemistry (1+, 2+, or 3+ in at least 10% of evaluated tumor cells) - Bidimensionally measurable disease - At least 20 mm x 10 mm by conventional techniques OR at least 10 mm x 10 mm by spiral CT scan - If the only site of measurable disease has been previously irradiated there must be disease progression in that site - Brain metastases allowed provided they are controlled and asymptomatic with no steroid therapy for at least 1 week PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN - Bilirubin no greater than 1.5 times ULN Renal - Creatinine clearance greater than 15 mL/min - Calcium no greater than ULN (treatment for hypercalcemia allowed) Cardiovascular - LVEF at least 45% by MUGA - No symptomatic ventricular arrhythmia - No symptomatic conduction abnormality - No myocardial infarction within the past year Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 1 month after study participation - HIV negative - No chronic medical condition or laboratory abnormality that would preclude study participation or compliance - No psychiatric condition that would preclude study participation or compliance - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix - No hypersensitivity to any ingredients of the study drug or Staphylococcus A protein PRIOR CONCURRENT THERAPY: Biologic therapy - No prior anti-epidermal growth factor receptor (EGFR) therapy - No other concurrent anti-EGFR therapy Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics - Prior steroid therapy for NSCLC allowed Radiotherapy - See Disease Characteristics - More than 2 weeks since prior radiotherapy - Concurrent local radiotherapy to bone lesions allowed provided no more than 10% of bone marrow is irradiated - No concurrent radiotherapy to lesions being evaluated to assess response Surgery - Prior surgery for NSCLC allowed Other - More than 30 days since prior investigational therapy - No other prior therapy for NSCLC - No concurrent antihypercalcemic treatment as cancer therapy for bone disease - No other concurrent investigational drugs - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DianePrager, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Diane Prager 310-794-7758
Additional Information:
Study ID Numbers: CDR0000327748; AMGEN-20025404,UCLA-0304051,ABX-0304,IMMUNEX-054.0004
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068562
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
2. Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer
3. Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
4. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
5. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibody Plus Carboplatin and Paclitaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
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