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

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ClinicalTrials.gov Identifier: NCT00660842
Recruitment Status : Active, not recruiting
First Posted : April 17, 2008
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

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 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
Study Start Date : November 2008
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources

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



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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
Italy
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
Bergamo, BG, Italy, 24128
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
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
Policlinico Universitario
Bari, Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
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
Azienda Ospedaliera D. Cotugno
Napoli, Italy, 80131
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, Italy, 80131
Università Federico II, Cattedra di Oncologia Medica
Napoli, Italy
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. University of Campania "Luigi Vanvitelli"

Publications of Results:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00660842     History of Changes
Other Study ID Numbers: MITO-7
2008-001754-40 ( EudraCT Number )
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

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
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action