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RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients with ovarian epithelial cancer, primary peritoneal cancer, and fallopian tube cancer.
PURPOSE: This randomized phase II/III trial is comparing the side effects of three combination chemotherapy regimens and to see how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
- 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 chemotherapy.
- 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 unacceptable toxicity.
- 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 toxicity.
- 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
Fallopian Tube Cancer
carboplatin, cisplatin, paclitaxel, quality-of-life assessment
Tom Baker Cancer Centre - Calgary
NCIC Clinical Trials Group
Published on BioPortfolio: 2014-08-27T03:18:45-0400
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