Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and
gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing. It is not yet known whether
liposome-encapsulated doxorubicin citrate is more effective when given together with or
without gemcitabine hydrochloride in killing tumor cells.
PURPOSE: This randomized phase II trial is studying liposome-encapsulated doxorubicin
citrate given together with gemcitabine hydrochloride to see how well it works compared with
liposome-encapsulated doxorubicin citrate alone in treating patients with ovarian epithelial
cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
regimens.
- 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
unacceptable toxicity.
- 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
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