Overview

Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
Female
Summary
Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly in patients with platinum -resistant ovarian cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Treatments:
Gemcitabine
Topotecan
Criteria
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
125

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

- 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