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Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

Primary Purpose

Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Topotecan
Gemcitabine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Cancer focused on measuring Ovarian cancer, peritoneal cancer, cancer, Fallopian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease. At least 4 weeks since last surgery or radiation therapy. Must have had a treatment-free interval of greater than 6 months following response to platinum. ECOG performance status of 0,1, or 2. Exclusion Criteria: Women of child-bearing potential that do not practice adequate contraception. Pregnant or lactating. Received more than one primary chemotherapy regimen. Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years. Active uncontrolled infection requiring antibiotics. Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study. Received radiation to more than 10% of bone. Prior treatment with topotecan or gemcitabine. Hypersensitivity to camptothecin or nucleoside analogues. Use of an investigational agent within 30 days.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

response duration time to response time to progression survival safety

Full Information

First Posted
May 23, 2003
Last Updated
June 8, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00061308
Brief Title
Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
Official Title
An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment. Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer
Keywords
Ovarian cancer, peritoneal cancer, cancer, Fallopian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Topotecan
Primary Outcome Measure Information:
Title
response rate
Secondary Outcome Measure Information:
Title
response duration time to response time to progression survival safety

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease. At least 4 weeks since last surgery or radiation therapy. Must have had a treatment-free interval of greater than 6 months following response to platinum. ECOG performance status of 0,1, or 2. Exclusion Criteria: Women of child-bearing potential that do not practice adequate contraception. Pregnant or lactating. Received more than one primary chemotherapy regimen. Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years. Active uncontrolled infection requiring antibiotics. Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study. Received radiation to more than 10% of bone. Prior treatment with topotecan or gemcitabine. Hypersensitivity to camptothecin or nucleoside analogues. Use of an investigational agent within 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD, PhD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
GSK Investigational Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
GSK Investigational Site
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
GSK Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31902
Country
United States
Facility Name
GSK Investigational Site
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
GSK Investigational Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
GSK Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
GSK Investigational Site
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Montana
ZIP/Postal Code
63117
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7570
Country
United States
Facility Name
GSK Investigational Site
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3788
Country
United States
Facility Name
GSK Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
GSK Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

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