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

• ClinicalTrials.gov Identifier: NCT00660842
• Recruitment Status: Active, not recruiting
• First Posted: April 17, 2008
• Last Update Posted: March 24, 2023
• Sponsor: National Cancer Institute, Naples
• Information provided by (Responsible Party): National Cancer Institute, Naples

Tracking Information

• First Submitted Date: April 15, 2008
• First Posted Date: April 17, 2008
• Last Update Posted Date: March 24, 2023
• Actual Study Start Date: November 2008
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 26, 2010)

• quality of life [ Time Frame: 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 ]

• Original Primary Outcome Measures (submitted: April 15, 2008): quality of life [ Time Frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy ]

Current Secondary Outcome Measures (submitted: November 26, 2010)

• overall survival [ Time Frame: 24 months ]
• response rate [ Time Frame: after 9 and 18 weeks of therapy ]
• toxicity [ Time Frame: weekly during therapy ]
• describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis [ Time Frame: 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 ]
• describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' [ Time Frame: at study entry ]

Original Secondary Outcome Measures (submitted: April 15, 2008)

• progression free survival
• overall survival
• response rate [ Time Frame: after 9 and 18 weeks of therapy ]
• toxicity [ Time Frame: weekly during therapy ]
• describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis [ Time Frame: 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 ]
• describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay' [ Time Frame: at study entry ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
• Official Title: Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
• Brief Summary: 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.
• 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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ovarian Cancer

Intervention

• Procedure: carboplatin
  AUC 6 IV day 1 every 21 days
• 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

Study Arms

• Experimental: A
  weekly chemotherapy
  Interventions:

  • Drug: carboplatin
  • Drug: paclitaxel
• Active Comparator: B
  every 3 weeks chemotherapy
  Interventions:

  • Procedure: carboplatin
  • Drug: paclitaxel

• Publications *: Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2014 Apr;15(4):396-405. doi: 10.1016/S1470-2045(14)70049-X. Epub 2014 Feb 28.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 26, 2010): 800
• Original Estimated Enrollment (submitted: April 15, 2008): 400
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00660842
• Other Study ID Numbers: MITO-7; 2008-001754-40 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Cancer Institute, Naples
• Original Responsible Party: Sandro Pignata, National Cancer Institute Naples
• Current Study Sponsor: National Cancer Institute, Naples
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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.; University of Campania "Luigi Vanvitelli"

• PRS Account: National Cancer Institute, Naples
• Verification Date: March 2023