Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Portland, Oregon 97239


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.


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



Primary Contact:

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

Backup Contact:


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: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.