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

Phase 3

Active, not recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: carboplatin; Drug: paclitaxel

• Registration Number: NCT00660842
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-17
• Study Start: 2008-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	carboplatin	weekly chemotherapy
A	paclitaxel	weekly chemotherapy
B	carboplatin	every 3 weeks chemotherapy
B	paclitaxel	every 3 weeks chemotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
overall survival	24 months
response rate	after 9 and 18 weeks of therapy
toxicity	weekly during therapy
describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis	at study entry
describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)	at study entry
describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'	at study entry

Trial Locations

Locations (28)

Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia; 🇮🇹 Roma, Italy

A.O. Univeristaria Policlinico; 🇮🇹 Modena, Italy

Ospedale Civile S. Spirito; 🇮🇹 Pescara, Italy

Azienda Ospedaliera V. Cervello; 🇮🇹 Palermo, PA, Italy

IRCCS Oncologico Bari, Oncologia Medica; 🇮🇹 Bari, BA, Italy

Universita di Bari Policinico I Clinical Ostetrica e Ginecologica; 🇮🇹 Bari, Italy

Azienda Ospedaliera C. Poma; 🇮🇹 Mantova, MN, Italy

Ospedale S. Chiara; 🇮🇹 Trento, TN, Italy

Azienda Ospedaliera D. Cotugno; 🇮🇹 Napoli, Italy

Policlinico Universitario; 🇮🇹 Bari, Italy

Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia; 🇮🇹 Bergamo, BG, Italy

A.O. di Udine S. Maria della Misericordia; 🇮🇹 Udine, Italy

Ospedale Fatebenefratelli, U.O. di Oncologia; 🇮🇹 Benevento, BN, Italy

Università Cattolica del Sacro Cuore, Dipartimento di Oncologia; 🇮🇹 Campobasso, CB, Italy

Ospedale S. Massimo, Day Hospital Oncologico; 🇮🇹 Penne, PE, Italy

Ospedale Mazzoni; 🇮🇹 Ascoli Piceno, Italy

Ospedale Fatebenefratelli; 🇮🇹 Benevento, Italy

Ospedale Senatore Antonio Perrino; 🇮🇹 Brindisi, Italy

Universita Cattolica del Sacro Cuore; 🇮🇹 Campobasso, Italy

Ospedale A. Manzoni; 🇮🇹 Lecco, Italy

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico; 🇮🇹 Napoli, Italy

Università Federico II, Cattedra di Oncologia Medica; 🇮🇹 Napoli, Italy

Ospedale Silvestrini; 🇮🇹 Perugia, Italy

A.O. S. Maria degli Angeli; 🇮🇹 Pordenone, Italy

Azienda Ospedaliera G. Rummo; 🇮🇹 Benevento, BN, Italy

Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C; 🇮🇹 Aviano, PN, Italy

Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica; 🇮🇹 Vicenza, VI, Italy

Istituto Nazionale Tumori; 🇮🇹 Milano, Italy