Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer (MITO-7)

March 23, 2023 updated by: National Cancer Institute, Naples

Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study

The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ascoli Piceno, Italy
        • Ospedale Mazzoni
      • Bari, Italy
        • Policlinico Universitario
      • Bari, Italy
        • Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
      • Benevento, Italy
        • Ospedale Fatebenefratelli
      • Brindisi, Italy
        • Ospedale Senatore Antonio Perrino
      • Campobasso, Italy
        • Universita Cattolica del Sacro Cuore
      • Lecco, Italy
        • Ospedale A. Manzoni
      • Milano, Italy
        • Istituto Nazionale Tumori
      • Modena, Italy
        • A.O. Univeristaria Policlinico
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
      • Napoli, Italy
        • Università Federico II, Cattedra di Oncologia Medica
      • Napoli, Italy, 80131
        • Azienda Ospedaliera D. Cotugno
      • Perugia, Italy
        • Ospedale Silvestrini
      • Pescara, Italy
        • Ospedale Civile S. Spirito
      • Pordenone, Italy
        • A.O. S. Maria degli Angeli
      • Roma, Italy
        • Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia
      • Udine, Italy
        • A.O. di Udine S. Maria della Misericordia
    • BA
      • Bari, BA, Italy, 70126
        • IRCCS Oncologico Bari, Oncologia Medica
    • BG
      • Bergamo, BG, Italy, 24128
        • Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
    • BN
      • Benevento, BN, Italy
        • Azienda Ospedaliera G. Rummo
      • Benevento, BN, Italy, 82100
        • Ospedale Fatebenefratelli, U.O. di Oncologia
    • CB
      • Campobasso, CB, Italy, 86100
        • Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
    • MN
      • Mantova, MN, Italy, 46100
        • Azienda Ospedaliera C. Poma
    • PA
      • Palermo, PA, Italy
        • Azienda Ospedaliera V. Cervello
    • PE
      • Penne, PE, Italy, 65017
        • Ospedale S. Massimo, Day Hospital Oncologico
    • PN
      • Aviano, PN, Italy, 33081
        • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
    • TN
      • Trento, TN, Italy, 38100
        • Ospedale S. Chiara
    • VI
      • Vicenza, VI, Italy, 36100
        • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV
  • Indication for chemotherapy
  • Age > 18 years
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher)
  • Performance Status (ECOG) > or = 3.
  • Previous chemotherapy
  • Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
  • Neutrophils < 2000 x mm3, platelets < 100000 x mm3
  • Inadequate renal function (creatinine > or = 1.25 x normal values) or liver function (ALT or AST > or = 1.25 x normal values)
  • Present or suspected hemorrhagic syndromes
  • Inability to comply with protocol and follow-up
  • Inability to access study site for clinical visits
  • Refusal of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
weekly chemotherapy
Drug: paclitaxel
175 mg/m2 IV day 1 every 21 days
Drug: carboplatin
AUC 2 IV every week
Drug: paclitaxel
60mg/m2 IV every week
Active Comparator: B
every 3 weeks chemotherapy
Drug: paclitaxel
175 mg/m2 IV day 1 every 21 days
Drug: paclitaxel
60mg/m2 IV every week
Procedure: carboplatin
AUC 6 IV day 1 every 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
progression free survival
Time Frame: every 6 months
every 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 24 months
24 months
response rate
Time Frame: after 9 and 18 weeks of therapy
after 9 and 18 weeks of therapy
toxicity
Time Frame: weekly during therapy
weekly during therapy
describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis
Time Frame: at study entry
at study entry
describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)
Time Frame: at study entry
at study entry
describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'
Time Frame: at study entry
at study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2008

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITO-7
  • 2008-001754-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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