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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00660842
Recruitment Status : Active, not recruiting
First Posted : April 17, 2008
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: carboplatin Drug: paclitaxel Drug: carboplatin Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : November 2008
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. quality of life [ Time Frame: weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy ]
  2. progression free survival [ Time Frame: every 6 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660842


Locations
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Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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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"
More Information
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Publications of Results:
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.

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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00660842    
Other Study ID Numbers: MITO-7
2008-001754-40 ( EudraCT Number )
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Keywords provided by National Cancer Institute, Naples:
quality of life
weekly therapy
neurotoxicity
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
 Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action