Randomized Phase II AGO-Study Comparing Combined Liposomal Doxorubicin (Myocet) and Gemcitabine (Gemzar) With Liposomal Doxorubicin (Myocet) Monotherapy in Platinum-Refractory and Platinum-Resistant Epithelial Cancer of the Ovary, Fallopian Tube and the Peritoneum
- To assess the response rate to liposome-encapsulated doxorubicin citrate and
gemcitabine hydrochloride versus liposome-encapsulated doxorubicin citrate alone in
patients with platinum-refractory or platinum-resistant ovarian epithelial, fallopian
tube, or primary peritoneal cavity cancer.
- To assess the quality of life of patients treated with these regimens.
- To determine the progression-free and overall survival of patients treated with these
- To determine the toxicity of these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to disease
(platinum-refractory disease vs platinum-resistant disease. Patients are randomized to 1 of
2 treatment arms.
- Arm I: Patients receive liposome-encapsulated doxorubicin citrate IV over 60 minutes on
day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment
repeats every 3 weeks for 6 courses in the absence of disease progression or
- Arm II: Patients receive liposome-encapsulated doxorubicin citrate IV over 60 minutes
on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients who experience clinical benefit after completion of 6 courses of chemotherapy may
continue therapy at the discretion of the investigator.
Patients complete quality-of-life questionnaires (EORTC-QLQ30 and QLQ-OV28) at baseline,
during, and after completion of study therapy. After completion of study treatment, patients
are followed up every 3 months for up to 1 year.
Allocation: Randomized, Primary Purpose: Treatment
Remission rates (complete response and partial response)
Medical University Innsbruck