Trial Information

A Randomized Phase III Study for the Treatment of Recurrent Epithelial Ovarian Cancer: Chemotherapy Alone Versus Chemotherapy Followed by Secondary Cytoreductive Surgery in Patients With a Treatment-Free Interval of More Than 12 Months

OBJECTIVES:

- Compare survival and progression free survival in patients with ovarian epithelial
cancer after receiving treatment with chemotherapy with or without secondary
cytoreductive surgery.

- Determine the toxicity of these treatment regimens in these patients.

- Determine the complications related to surgical treatment in these patients.

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

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage
at initial diagnosis (early stage I-IIa vs advanced stage IIb-IV), length of interval from
end of prior first line chemotherapy (1-2 years vs more than 2 years), response to first 3
courses of second line induction chemotherapy in this study (no change vs partial remission
vs complete remission), number of measurable tumor lesions (1 vs more than 1), largest tumor
size of recurrence (less than 5 cm vs 5 cm or more), and participating center.

Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week
regimen or 6 courses of a weekly regimen of platinum based (cisplatin or carboplatin)
therapy. Patients with no change, partial remission, or complete remission are randomized to
one of two treatment arms.

- Arm I: Patients undergo secondary cytoreductive surgery within 14 days of
randomization. Within 8 weeks after the last preoperative chemotherapy course, patients
continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses
in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients continue platinum based chemotherapy for at least 3 additional courses
as in arm I.

Quality of life is assessed at baseline; before the 4th or 6th course of chemotherapy or 1
week before surgery; after the 6th course of chemotherapy in the chemotherapy only arm OR
before the 4th or 6th course of chemotherapy in the surgery arm; 2 months after chemotherapy
or after the 6th course of chemotherapy in the surgery arm; and then every 6 months for up
to 5 years.

Patients are followed every 3 months for 2 years, and then every 6 months for 3 years or
until disease progression.

PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 5 years.