NCT00401674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Jun 2003

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

5 years

First QC Date

November 17, 2006

Last Update Submit

January 13, 2016

Conditions

Ovarian Cancer

Keywords

ovarian cancerelderlyweekly chemotherapyfirst-line

Outcome Measures

Primary Outcomes (2)

  • Objective response rate

    6 month

  • Toxicity

    assessed weekly

    up to 6 months

Secondary Outcomes (1)

  • possible predictive factors of the geriatric ADL and IADL scales

    6 months

Study Arms (1)

SINGLE ARM

EXPERIMENTAL
Drug: carboplatinDrug: paclitaxel

Interventions

carboplatinDRUG
SINGLE ARM
paclitaxelDRUG
SINGLE ARM

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ospedale Fatebenefratelli, U.O. di Oncologia

Benevento, BN, 82100, Italy

Location

Università Cattolica del Sacro Cuore, Dipartimento di Oncologia

Campobasso, CB, 86100, Italy

Location

Ospedale Cannizzaro

Cannizzaro, CT, Italy

Location

Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia

Mantova, MN, 46100, Italy

Location

Ospedale S. Massimo

Penne, PE, Italy

Location

Ospedale S. Giovanni Calibita Fatebenefratelli

Roma, Roma, 00186, Italy

Location

Ospedale Civile Umberto I, Day Hospital Oncoematologico

Nocera Inferiore, SA, 84014, Italy

Location

Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

Vicenza, VI, 36100, Italy

Location

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, 80131, Italy

Location

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C

Napoli, 80131, Italy

Location

Related 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 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.

    PMID: 18243011RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Sandro Pignata, M.D., Ph.D

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR

  • Francesco Perrone, M.D., Ph.D

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

June 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

IT(10)