A Phase II/III Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy
- To determine if intraperitoneal platinum-based chemotherapy leads to improved
progression-free and overall survival as compared with intravenous chemotherapy in
patients with stage IIB-III or stage IV (on the basis of pleural effusion only with
positive cytology) ovarian epithelial, serous type peritoneal, or fallopian tube cancer
who have received optimal debulking surgery following neoadjuvant intravenous
- To identify which of the two IP regimens will continue into the phase III portion of
the trial. (Phase II)
- To compare the efficacy of the selected IP plus IV chemotherapy regimen versus IV
carboplatin plus paclitaxel in these patients. (Phase III)
- To compare IP plus IV chemotherapy versus IV carboplatin plus paclitaxel with respect
to overall survival, toxic effects, quality of life, and economic evaluation.
- To determine components of nursing interventions associated with administering
intraperitoneal therapy and to correlate these interventions with treatment efficacy,
toxic effects, and quality of life.
OUTLINE: This is a multicenter study. Patients are stratified according to cooperative
group, residual disease (observable [e.g., macroscopic] disease that is evident at end of
delayed primary debulking surgery vs no evidence of observable disease at end of delayed
primary debulking surgery), reason for delayed primary debulking surgery at initial
diagnosis (nonresectable disease vs other reasons), and timing of intraperitoneal catheter
insertion (intra-operative catheter insertion vs post-operative insertion).
- Phase II: Patients are randomized to 1 of 3 treatment groups.
- Arm I: Patients receive paclitaxel IV over 3 hours on day 1 and over 1 hour on day
8. Patients also receive carboplatin IV over 30 minutes on day 1. Treatment
repeats every 21 days for 3 courses in the absence of disease progression or
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1 and intraperitoneally
(IP) on day 8. Patients also receive cisplatin IP on day 1. Treatment repeats
every 21 days for 3 courses in the absence of disease progression or unacceptable
- Arm III: Patients receive paclitaxel IV over 3 hours on day 1 and IP on day 8.
Patients also receive carboplatin IP on day 1. Treatment repeats every 21 days for
3 courses in the absence of disease progression or unacceptable toxicity.
- Phase III: Patients are randomized to 1 of 2 treatment groups.
- Arm I: Patients receive paclitaxel and carboplatin as in phase II, arm I.
- Arm II: Patients receive paclitaxel and cisplatin as in phase II, arm II or
paclitaxel and carboplatin as in phase II, arm III.
Patients complete quality of life questionnaires EORTC QLQ-C30, ovarian cancer module (EORTC
QLQ-OV28), and FACT/GOG-Ntx at baseline, on day 1 of courses 2 and 3, at 3, 6 and 12 months
after completion of study treatment, and then annually until disease progression, death, or
initiation of second-line therapy.
After completion of study treatment, patients are followed at 6 weeks, every 3 months for 2
years, every 6 months for 2 years, and then annually until progression, death, or initiation
of second-line therapy.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
9-month progression rate post-randomization
Helen J. Mackay, MD
Princess Margaret Hospital, Canada
Canada: Health Canada
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Women and Infants Hospital of Rhode Island||Providence, Rhode Island 02905|
|CoxHealth||Springfield, Missouri 65807|
|Mercy-Springfield||Springfield, Missouri 65804|
|Univ of Utah (Huntsman Cancer Institute)||Salt Lake City, Utah 84132|
|Northwest CCOP - Multicare Health System||Tacoma, Washington 98415|