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A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms

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Trial Information

A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer


Brief Overview of

Inclusion Criteria:



- Patients must have pathologically confirmed ovarian cancer, which is advanced or
recurrent carcinoma, who have failed at least two, but no more than three prior
therapies for metastatic disease

- Patients must have > 20% Lewis-y antigen expression documented by
immunohistochemistry

- LVEF > 50% by echo or MUGA

- Must be platinum resistant as defined by:

- Progression while on initial platinum therapy or

- Progression while on retreatment with initial platinum regimen or

- Relapse < 6 months after initial therapy

Brief Overview of Exclusion Criteria:

- Patients who have had prior therapy with Gemzar®

- Cumulative anthracycline exposure > 300 mg/m2

- More than three prior chemotherapy regimens for ovarian cancer (Retreatment with
Taxane/Platinum after initial combination is considered only one regimen)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Andrew Sandler, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG015-0003

NCT ID:

NCT00051584

Start Date:

Completion Date:

May 2003

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Virginia Mason Medical CenterSeattle, Washington  98111
Mountain States Tumor InstituteBoise, Idaho  83712
Sharp HealthcareSan Diego, California  92121
Arlington Fairfax Hematology OncologyArlington, Virginia  22205
California Hematology Oncology Medical GroupTorrance, California  90505