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Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Ovarian Cancer

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Trial Information

Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed ovarian adenocarcinoma

- Patients had to have received a front-line, platinum- based chemotherapy regimen

- Patients who progressed or whose best response to their most recent platinum-based
therapy was less than a partial response will be classified as having
platinum-refractory/resistant ovarian cancer. This category also will include
patients with disease progression within six months of completing the most recent
platinum-based chemotherapy

- Patients had to have at least one bidimensionally measurable and/or evaluable
(unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca

- A >= 4 weeks interval between their last chemotherapy regimen and the start of study

- Age > 18 years old

- Performance status (WHO) 0-2

- Life expectancy of at least three months

- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count
> 100000/mm^3, hemoglobin > 9 gr/mm^3)

- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
upper limit of normal) and renal function (creatinine < 2 mg/dl)

- Informed consent

Exclusion Criteria:

- Pregnant or nursing

- Psychiatric illness or social situation that would preclude study compliance

- Other concurrent uncontrolled illness

- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Antonia Kalikaki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology


Greece: National Organization of Medicines

Study ID:




Start Date:

June 2006

Completion Date:

July 2011

Related Keywords:

  • Ovarian Cancer
  • Cancer;
  • Ovarian cancer;
  • Recurrent ovarian cancer platinum-resistant
  • Ovarian Neoplasms