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

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: Hycamptin

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00429559

CT/06.14

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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