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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00401674
First received: November 17, 2006
Last updated: January 13, 2016
Last verified: January 2016

November 17, 2006
January 13, 2016
June 2003
June 2008   (final data collection date for primary outcome measure)
  • Objective response rate [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    assessed weekly
  • Objective response rate
  • Toxicity
Complete list of historical versions of study NCT00401674 on ClinicalTrials.gov Archive Site
possible predictive factors of the geriatric ADL and IADL scales [ Time Frame: 6 months ] [ Designated as safety issue: No ]
possible predictive factors of the geriatric ADL and IADL scales
Not Provided
Not Provided
 
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.
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.
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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • Drug: carboplatin
  • Drug: paclitaxel
Experimental: SINGLE ARM
Interventions:
  • Drug: carboplatin
  • Drug: paclitaxel
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Female
70 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00401674
MITO-5
Not Provided
Not Provided
Not Provided
National Cancer Institute, Naples
National Cancer Institute, Naples
Not Provided
Principal Investigator: Sandro Pignata, M.D., Ph.D National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute, Naples
National Cancer Institute, Naples
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP