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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00401674

Acronym

MITO-5

Enrollment

Registered

2006-11-20

Start date

2003-06-30

Completion date

2008-06-30

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

ovarian cancer, elderly, weekly chemotherapy, first-line

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.

Interventions

DRUGcarboplatin

DRUGpaclitaxel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Objective response rate	6 month	—
Toxicity	up to 6 months	assessed weekly

Secondary

Measure	Time frame
possible predictive factors of the geriatric ADL and IADL scales	6 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026