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SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Seattle Genetics, Inc.
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031603
  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.


Condition Intervention Phase
Lung Cancer
Drug: cBR96-doxorubicin immunoconjugate
Drug: docetaxel
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Docetaxel BMS 182248
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Phase II Study Using SGN-15 (cBR96 - Doxorubicin Immunoconjugate) in Combination With Taxotere for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031603

Locations
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Chair: Dennis M. Miller, PhD, DABT Seattle Genetics, Inc.
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069080, SGEN-SG0002-015
Study First Received: March 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00031603  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Recurrence
Doxorubicin
Carcinoma
Antibodies, Monoclonal
Docetaxel
Antibodies
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Immunoconjugates
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009