Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer

National Cancer Institute, Naples800 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

800

Conditions

Ovarian Cancer

Interventions

carboplatinPROCEDURE

AUC 6 IV day 1 every 21 days

paclitaxelDRUG

175 mg/m2 IV day 1 every 21 days

carboplatinDRUG

AUC 2 IV every week

paclitaxel

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

IRCCS Oncologico Bari, Oncologia Medica

Outcomes

Primary Outcomes

quality of life

Time frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy

progression free survival

Time frame: every 6 months

Secondary Outcomes

overall survival

Time frame: 24 months

response rate

Time frame: after 9 and 18 weeks of therapy

toxicity

Time frame: weekly during therapy

describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis

Time frame: at study entry

describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)

Time frame: at study entry

describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'

Time frame: at study entry

Data from ClinicalTrials.gov

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