MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

— MITO-5  

Official title:

Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401674
• Other study ID #: MITO-5
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2006
• Last updated: January 13, 2016
• Start date: June 2003
• Est. completion date: June 2008

Study information

• Verified date: January 2016
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage IC-IV.

Description:

This is a phase II multicenter study. The experimental treatment is carboplatin (AUC 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Age 70 years or greater

• Cytologic / histologic diagnosis ovarian cancer

• Stage of disease at diagnosis IC -IV

• Performance status (ECOG) < 3

• Indication for chemotherapy treatment

• Written informed consent

Exclusion Criteria:

• Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)

• Cerebral metastases

• Neutrophils < 1000/mm3, platelets < 100000/mm3, hemoglobin < 8g/dl

• Creatinine > o = 1.25 times the upper normal limit

• GOT or GPT > o = 1.25 times the upper normal limit, except in case of liver metastases)

• Patient's inability to comply with followup

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• carboplatin

• paclitaxel

Locations

Country	Name	City	State
Italy	Ospedale Fatebenefratelli, U.O. di Oncologia	Benevento	BN
Italy	Università Cattolica del Sacro Cuore, Dipartimento di Oncologia	Campobasso	CB
Italy	Ospedale Cannizzaro	Cannizzaro	CT
Italy	Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia	Mantova	MN
Italy	Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B	Napoli
Italy	Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Napoli
Italy	Ospedale Civile Umberto I, Day Hospital Oncoematologico	Nocera Inferiore	SA
Italy	Ospedale S. Massimo	Penne	PE
Italy	Ospedale S. Giovanni Calibita Fatebenefratelli	Roma
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, Breda E, Scambia G, Pisano C, Zagonel V, Lorusso D, Greggi S, De Vivo R, Ferrandina G, Gallo C, Perrone F. A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer. A Multice — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		6 month	No
Primary	Toxicity	assessed weekly	up to 6 months	Yes
Secondary	possible predictive factors of the geriatric ADL and IADL scales		6 months	No