Ovarian Cancer
Conditions
Keywords
quality of life, weekly therapy, neurotoxicity
Brief summary
The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.
Detailed description
The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.
Interventions
PROCEDUREcarboplatin
AUC 6 IV day 1 every 21 days
DRUGpaclitaxel
175 mg/m2 IV day 1 every 21 days
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV * Indication for chemotherapy * Age \> 18 years * Life expectancy of at least 3 months
Exclusion criteria
* Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher) * Performance Status (ECOG) \> or = 3. * Previous chemotherapy * Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias) * Neutrophils \< 2000 x mm3, platelets \< 100000 x mm3 * Inadequate renal function (creatinine \> or = 1.25 x normal values) or liver function (ALT or AST \> or = 1.25 x normal values) * Present or suspected hemorrhagic syndromes * Inability to comply with protocol and follow-up * Inability to access study site for clinical visits * Refusal of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality of life | weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy |
| progression free survival | every 6 months |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | weekly during therapy |
| describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis | at study entry |
| overall survival | 24 months |
| describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' | at study entry |
| describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) | at study entry |
| response rate | after 9 and 18 weeks of therapy |
Countries
Italy
Outcome results
None listed