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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00660842
First received: April 15, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Procedure: carboplatin
Drug: paclitaxel
Drug: carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • quality of life [ Time Frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: after 9 and 18 weeks of therapy ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: weekly during therapy ] [ Designated as safety issue: Yes ]
  • describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis [ Time Frame: at study entry ] [ Designated as safety issue: No ]
  • describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) [ Time Frame: at study entry ] [ Designated as safety issue: No ]
  • describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' [ Time Frame: at study entry ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
weekly chemotherapy
Drug: carboplatin
AUC 2 IV every week
Drug: paclitaxel
60mg/m2 IV every week
Active Comparator: B
every 3 weeks chemotherapy
Procedure: carboplatin
AUC 6 IV day 1 every 21 days
Drug: paclitaxel
175 mg/m2 IV day 1 every 21 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660842

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

No publications provided by National Cancer Institute, Naples

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00660842     History of Changes
Other Study ID Numbers: MITO-7, 2008-001754-40
Study First Received: April 15, 2008
Last Updated: July 29, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
quality of life
weekly therapy
neurotoxicity

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014