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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Principal Investigator

GSK Clinical Trials, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Canada: Health Canada

Study ID:

104864/627

NCT ID:

NCT00061308

Start Date:

December 2002

Completion Date:

Related Keywords:

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

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteSt. Louis, Montana  63110
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteHattiesburg, Mississippi  39401