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

Ovarian Cancer Clinical Trial

— MITO-7  

Official title:

Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00660842
• Other study ID #: MITO-7
• Secondary ID: 2008-001754-40
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2008
• Est. completion date: November 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• carboplatin
AUC 6 IV day 1 every 21 days

Drug:
• paclitaxel
175 mg/m2 IV day 1 every 21 days
• carboplatin
AUC 2 IV every week
• paclitaxel
60mg/m2 IV every week

Locations

Country	Name	City	State
Italy	Ospedale Mazzoni	Ascoli Piceno
Italy	Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C	Aviano	PN
Italy	IRCCS Oncologico Bari, Oncologia Medica	Bari	BA
Italy	Policlinico Universitario	Bari
Italy	Universita di Bari Policinico I Clinical Ostetrica e Ginecologica	Bari
Italy	Azienda Ospedaliera G. Rummo	Benevento	BN
Italy	Ospedale Fatebenefratelli	Benevento
Italy	Ospedale Fatebenefratelli, U.O. di Oncologia	Benevento	BN
Italy	Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia	Bergamo	BG
Italy	Ospedale Senatore Antonio Perrino	Brindisi
Italy	Universita Cattolica del Sacro Cuore	Campobasso
Italy	Università Cattolica del Sacro Cuore, Dipartimento di Oncologia	Campobasso	CB
Italy	Ospedale A. Manzoni	Lecco
Italy	Azienda Ospedaliera C. Poma	Mantova	MN
Italy	Istituto Nazionale Tumori	Milano
Italy	A.O. Univeristaria Policlinico	Modena
Italy	Azienda Ospedaliera D. Cotugno	Napoli
Italy	Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico	Napoli
Italy	Università Federico II, Cattedra di Oncologia Medica	Napoli
Italy	Azienda Ospedaliera V. Cervello	Palermo	PA
Italy	Ospedale S. Massimo, Day Hospital Oncologico	Penne	PE
Italy	Ospedale Silvestrini	Perugia
Italy	Ospedale Civile S. Spirito	Pescara
Italy	A.O. S. Maria degli Angeli	Pordenone
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia	Roma
Italy	Ospedale S. Chiara	Trento	TN
Italy	A.O. di Udine S. Maria della Misericordia	Udine
Italy	Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica	Vicenza	VI

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life		weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
Primary	progression free survival		every 6 months
Secondary	overall survival		24 months
Secondary	response rate		after 9 and 18 weeks of therapy
Secondary	toxicity		weekly during therapy
Secondary	describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis		at study entry
Secondary	describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)		at study entry
Secondary	describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'		at study entry