Epithelial Ovarian Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of paclitaxel and carboplatin followed by gemcitabine and carboplatin therapy for patients with epithelial ovarian cancer.
Interventions
DRUGgemcitabine
DRUGcarboplatin
DRUGpaclitaxel
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically verified epithelial ovarian cancer * FIGO stage III-IV * Patients with measurable disease. RECIST criteria with GCIG modifications will be used for response and for progression assessment. * Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal to 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal to 20 mm.
Exclusion criteria
* Ovarian tumors with low malignant potential (borderline tumors) * Non-epithelial ovarian or mixed epithelial. non epithelial tumors (e.g. mixed Mullerian tumors) * Time between definitive surgery and enrollment into the study is greater than 6 weeks * Patients who have received previous chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| 2-year survival | — |
| Toxicity | — |
| Dose intensity | — |
Countries
Slovakia
Outcome results
None listed