Ovarian Cancer
Conditions
Keywords
stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian germ cell tumor
Brief summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, 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) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.
Detailed description
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I) * Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II) Secondary * Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I) * Evaluate the safety profiles of this regimen in these patients. (Phase I) * Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II) * Determine the overall survival of patients treated with this regimen. (Phase II) * Determine the overall response in patients treated with this regimen. (Phase II) * Evaluate the safety and toxicity of this regimen in these patients. (Phase II) OUTLINE: This is a multicenter study. Patients receive paclitaxel-loaded polymeric micelle and carboplatin.
Interventions
DRUGcarboplatin
Sponsors
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced ovarian cancer * Measurable disease by RECIST criteria * No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 6 months * Clinically acceptable blood, kidney, and spleen function * Not pregnant or nursing * Fertile patients must use effective contraception * No preexisting sensory or motor neuropathy ≥ grade 1 * No other malignancies within the past 5 years PRIOR CONCURRENT THERAPY: * No prior chemotherapy for ovarian cancer * No prior immunotherapy or hormonal therapy for ovarian cancer * No prior radiotherapy to the pelvis or abdominal cavity * More than 2 weeks since prior major surgery other than debulking surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose and recommended phase II dose (Phase I) | — |
| Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate as measured by RECIST criteria (Phase II) | — |
| Overall survival (Phase II) | — |
| Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I) | — |
| Safety and toxicity (Phase II) | — |
| Overall response (Phase II) | — |
| Safety profiles (Phase I) | — |
Countries
South Korea
Outcome results
None listed