Clinical trial NCT00660842: Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
Official title: Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: quality of life
weekly therapy
neurotoxicity
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: quality of life
timeFrame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
measure: progression free survival
timeFrame: every 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 24 months
measure: response rate
timeFrame: after 9 and 18 weeks of therapy
measure: toxicity
timeFrame: weekly during therapy
measure: describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis
timeFrame: at study entry
measure: describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)
timeFrame: at study entry
measure: describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'
timeFrame: at study entry
Other outcomes:
Locations:
city: Bari
country: Italy
facility: IRCCS Oncologico Bari, Oncologia Medica
state: BA
city: Bergamo
country: Italy
facility: Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
state: BG
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli, U.O. di Oncologia
state: BN
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
state: BN
city: Campobasso
country: Italy
facility: Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
state: CB
city: Mantova
country: Italy
facility: Azienda Ospedaliera C. Poma
state: MN
city: Palermo
country: Italy
facility: Azienda Ospedaliera V. Cervello
state: PA
city: Penne
country: Italy
facility: Ospedale S. Massimo, Day Hospital Oncologico
state: PE
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
state: PN
city: Trento
country: Italy
facility: Ospedale S. Chiara
state: TN
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
state: VI
city: Ascoli Piceno
country: Italy
facility: Ospedale Mazzoni
city: Bari
country: Italy
facility: Policlinico Universitario
city: Bari
country: Italy
facility: Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli
city: Brindisi
country: Italy
facility: Ospedale Senatore Antonio Perrino
city: Campobasso
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: Lecco
country: Italy
facility: Ospedale A. Manzoni
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: Modena
country: Italy
facility: A.O. Univeristaria Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera D. Cotugno
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
city: Napoli
country: Italy
facility: Università Federico II, Cattedra di Oncologia Medica
city: Perugia
country: Italy
facility: Ospedale Silvestrini
city: Pescara
country: Italy
facility: Ospedale Civile S. Spirito
city: Pordenone
country: Italy
facility: A.O. S. Maria degli Angeli
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
city: Udine
country: Italy
facility: A.O. di Udine S. Maria della Misericordia
Study officials:
affiliation: National Cancer Institute, Naples
name: Sandro Pignata, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Marilina Piccirillo, M.D.,
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Ciro Gallo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2014 Apr;15(4):396-405. doi: 10.1016/S1470-2045(14)70049-X. Epub 2014 Feb 28.