Clinical trial NCT00401674: MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer
Official title: Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: ovarian cancer
elderly
weekly chemotherapy
first-line
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 26
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: 6 month
measure: Toxicity
timeFrame: up to 6 months
Secondary outcomes:
measure: possible predictive factors of the geriatric ADL and IADL scales
timeFrame: 6 months
Other outcomes:
Locations:
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli, U.O. di Oncologia
state: BN
city: Campobasso
country: Italy
facility: Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
state: CB
city: Cannizzaro
country: Italy
facility: Ospedale Cannizzaro
state: CT
city: Mantova
country: Italy
facility: Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
state: MN
city: Penne
country: Italy
facility: Ospedale S. Massimo
state: PE
city: Nocera Inferiore
country: Italy
facility: Ospedale Civile Umberto I, Day Hospital Oncoematologico
state: SA
city: Vicenza
country: Italy
facility: Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
state: VI
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli
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
References:
citation: 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 Multicentre Italian Trial in Ovarian cancer (MITO-5) study. Crit Rev Oncol Hematol. 2008 Jun;66(3):229-36. doi: 10.1016/j.critrevonc.2007.12.005. Epub 2008 Feb 1.