Expired Study
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Portland, Oregon 97239


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SGN-15 may be able to locate tumor cells and kill them without harming normal cells. Combining SGN-15 with docetaxel may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of metastatic or recurrent non-small cell lung cancer.


Study summary:

OBJECTIVES: - Determine the toxicity and safety profile of SGN-15 (cBR96-doxorubicin immunoconjugate) in combination with docetaxel in patients with advanced or recurrent non-small cell lung carcinoma. - Determine the clinical response rate and response duration in patients treated with this regimen. - Determine the progression-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a randomized, open-label study. Patients are stratified according to gender and performance status. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive SGN-15 (cBR96-doxorubicin immunoconjugate) IV over 2 hours followed by docetaxel IV over 30 minutes once weekly on weeks 1-3 and 5-7. - Arm II: Patients receive docetaxel as in arm I. Quality of life is assessed at baseline and on day 1 of each course. Patients are followed at 8 weeks. PROJECTED ACCRUAL: A total of 60 patients (40 in arm I and 20 in arm II) will be accrued for this study within 18-24 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic or recurrent (unresectable) non-small cell lung carcinoma - Failed at least 1 but no more than 2 prior therapies for metastatic disease OR - Disease recurrence within 6 months of completing prior adjuvant chemotherapy - Lewis-Y antigen expression by immunohistochemistry - Must have one of the following: - Bidimensionally or unidimensionally measurable disease by physical exam or imaging studies - Evaluable disease, including bone metastases defined on bone scan OR malignant pleural effusion - No uncontrolled, symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Hemoglobin at least 10 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 2.5 times normal - Alkaline phosphatase no greater than 2.5 times normal (unless documented bony metastasis) - Amylase/lipase no greater than 1.5 times normal - No hepatic failure - No hepatitis B or C Renal: - Creatinine no greater than 1.5 times upper limit of normal - No renal failure Cardiovascular: - Left ventricular function at least 50% by echocardiogram or MUGA scan - No congestive heart failure Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to recombinant human or murine proteins - No peripheral neuropathy grade 2 or greater - No active viral, bacterial, or systemic fungal infections - No known HIV - No other primary malignancy except: - Non-melanoma skin cancer - Carcinoma in situ of the cervix - Localized prostate cancer - Completely resected stage I or II disease with no evidence of recurrence, from which patient has remained disease-free for more than 3 years - No uncontrolled significant non-malignant disease - No uncontrolled peptic ulcer disease - No serious underlying medical condition that would preclude study participation - No dementia or altered mental status that would preclude informed consent PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 6 months since prior therapeutic or diagnostic murine/human chimeric antibodies or human monoclonal antibodies - Must be negative for BR96 antibodies in serum Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or anthracycline) - No prior docetaxel - Prior cumulative anthracycline exposure less than 300 mg/m^2 Endocrine therapy: - At least 4 weeks since prior hormonal therapy - No concurrent antineoplastic hormonal therapy, except estrogen replacement Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics Other: - No other concurrent anti-neoplastic agents - No other concurrent experimental agents - No concurrent immunosuppressive medications


NCT ID:

NCT00031603


Primary Contact:

Study Chair
Dennis M. Miller, PhD, DABT
Seattle Genetics, Inc.


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97239
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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