Back to resultsSafety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer
Primary Purpose
Ovarian Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SGN-15 (cBR96-Doxorubicin Immunoconjugate)
Gemzar (Gemcitabine)
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
Eligibility Criteria
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)
Sites / Locations
- Arizona Cancer Center
- Sharp Healthcare
- California Hematology Oncology Medical Group
- Mountain States Tumor Institute
- Arlington Fairfax Hematology Oncology
- Virginia Mason Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00051584
Brief Title
Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer
Official Title
A Phase II Study of SGN-15 (cBR96 - Doxorubicin Immunoconjugate) Combined With Gemzar® Versus Single-Agent Gemzar® in Patients With Advanced Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seagen Inc.
4. Oversight
5. Study Description
Brief Summary
This is an open-label, randomized phase II trial comparing treatment with a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly Gemzar® (Gemcitabine) to treatment with Gemzar® alone. The primary objectives of this study are to determine the toxicity and safety profile of the combination of SGN-15 and Gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with Gemzar® alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SGN-15 (cBR96-Doxorubicin Immunoconjugate)
Intervention Type
Drug
Intervention Name(s)
Gemzar (Gemcitabine)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Sandler, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Hematology Oncology Medical Group
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Arlington Fairfax Hematology Oncology
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy Study of SGN-15 (Antibody-Drug Conjugate) Combined With Gemcitabine in Patients With Ovarian Cancer
We'll reach out to this number within 24 hrs