CClinicalTrials.gg
CompletedNCT00061308Updated Jun 9, 2017

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

A Phase 2 interventional study of Topotecan and Gemcitabine in Peritoneal Cancer, Ovarian Cancer and Neoplasms, Ovarian, sponsored by GlaxoSmithKline. Completed at 19 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-09.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Peritoneal Cancer
  • Ovarian Cancer
  • Neoplasms, Ovarian
  • Fallopian Tube Cancer

Keywords

  • Ovarian cancer
  • peritoneal cancer
  • cancer
  • Fallopian cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 75 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Masking
None (open label)
Enrollment
75 participants

Interventions

  • DrugTopotecan
  • DrugGemcitabine

    Also known as: Topotecan

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What researchers measure

Primary outcomes

  1. response rate

Secondary outcomes

  1. response duration time to response time to progression survival safety

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Study locations

19 sites
  • GSK Investigational Site
    Los Gatos, California 95032, United States
  • GSK Investigational Site
    Santa Rosa, California 95403, United States
  • GSK Investigational Site
    Washington, D.C., District of Columbia 20010, United States
  • GSK Investigational Site
    Hollywood, Florida 33021, United States
  • GSK Investigational Site
    Columbus, Georgia 31902, United States
  • GSK Investigational Site
    Hinsdale, Illinois 60521, United States
  • GSK Investigational Site
    Lansing, Michigan 48912, United States
  • GSK Investigational Site
    Southfield, Michigan 48075, United States
  • GSK Investigational Site
    Hattiesburg, Mississippi 39401, United States
  • GSK Investigational Site
    St. Louis, Montana 63117, United States
  • GSK Investigational Site
    Rochester, New York 14620, United States
  • GSK Investigational Site
    Chapel Hill, North Carolina 27599-7570, United States
  • GSK Investigational Site
    Abington, Pennsylvania 19001-3788, United States
  • GSK Investigational Site
    Greenville, South Carolina 29601, United States
  • GSK Investigational Site
    Chattanooga, Tennessee 37403, United States
  • GSK Investigational Site
    Calgary, Alberta T2N 4N2, Canada
  • GSK Investigational Site
    Vancouver, British Columbia V5Z 4E6, Canada
  • GSK Investigational Site
    Ottawa, Ontario K1H 1C4, Canada
  • GSK Investigational Site
    Toronto, Ontario M4N 3M5, Canada
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00061308
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 28, 2003
Start date
Dec 2002
Primary completion
Sep 2004
Last update
Jun 9, 2017

Study contacts

GSK Clinical Trials, MD, PhD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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