Trial Information

A Randomized Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) Versus Paclitaxel/Carboplatin (TC) in the Treatment of Women With Advanced Ovarian Cancer

OBJECTIVES:

- Compare progression free survival and overall survival in patients with stage IIB, III,
or IV invasive ovarian epithelial, fallopian tube, or peritoneal cancer treated with
paclitaxel and carboplatin with or without epirubicin.

- Compare the toxicity of these 2 regimens in these patients.

- Compare the quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and type
of surgery (delayed surgery: 3 courses of chemotherapy before surgery vs primary surgery:
optimally debulked stage IIB or III [residual tumor less than 1 cm] vs primary surgery:
suboptimally debulked stage IV [residual tumor 1 cm or greater]).

Surgery

- Patients are assigned to one of two surgery groups:

- Group A: Patients undergo primary surgery comprised of hysterectomy, bilateral
salpingo-oophorectomy (BSO), omentectomy, and resection of all tumor masses, if
possible, before beginning chemotherapy. Patients with residual disease greater than 1
cm after completion of primary surgery receive 3 courses of chemotherapy, followed
within 6 weeks by interval debulking surgery, followed within 3 weeks by the fourth
course of chemotherapy.

- Group B: Patients undergo delayed surgery comprised of hysterectomy, BSO, omentectomy,
and resection of all tumor masses, if possible, after completion of 3 courses of
chemotherapy.

Chemotherapy

- Patients are randomized to 1 of 2 chemotherapy arms:

- Arm I: Patients receive epirubicin IV over 15-20 minutes, paclitaxel IV over 3 hours,
and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses.
Patients with residual tumor after completion of 6 courses may receive 3 additional
courses.

- Arm II: Patients receive paclitaxel and carboplatin as above but no epirubicin. Quality
of life is assessed before beginning study, after completion of courses 3, 6, and 9 (if
applicable), and then at 6 and 12 months after completion of study treatment.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.