Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer

NCT00660842 | Unknown Phase 3

• 2 other identifiers: MITO-72008-001754-40
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 28

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.

Conditions

Ovarian Cancer

Keywords

quality of life; weekly therapy; neurotoxicity

Outcome Measures

Primary Outcomes (2)

• quality of life

  weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy

• progression free survival

  every 6 months

Secondary Outcomes (6)

• overall survival

  24 months

• response rate

  after 9 and 18 weeks of therapy

• toxicity

  weekly during therapy

• describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis

  at study entry

• describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)

  at study entry

Study Arms (2)

A

EXPERIMENTAL

weekly chemotherapy

Drug: carboplatin; Drug: paclitaxel

B

ACTIVE COMPARATOR

every 3 weeks chemotherapy

Procedure: carboplatin; Drug: paclitaxel

Interventions

carboplatin PROCEDURE

AUC 6 IV day 1 every 21 days

B

paclitaxel DRUG

175 mg/m2 IV day 1 every 21 days

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (28)

IRCCS Oncologico Bari, Oncologia Medica

Bari, BA, 70126, Italy

Location

Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia

Bergamo, BG, 24128, Italy

Location

Ospedale Fatebenefratelli, U.O. di Oncologia

Benevento, BN, 82100, Italy

Location

Azienda Ospedaliera G. Rummo

Benevento, BN, Italy

Location

Università Cattolica del Sacro Cuore, Dipartimento di Oncologia

Campobasso, CB, 86100, Italy

Location

Azienda Ospedaliera C. Poma

Mantova, MN, 46100, Italy

Location

Azienda Ospedaliera V. Cervello

Palermo, PA, Italy

Location

Ospedale S. Massimo, Day Hospital Oncologico

Penne, PE, 65017, Italy

Location

Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C

Aviano, PN, 33081, Italy

Location

Ospedale S. Chiara

Trento, TN, 38100, Italy

Location

Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica

Vicenza, VI, 36100, Italy

Location

Ospedale Mazzoni

Ascoli Piceno, Italy

Location

Policlinico Universitario

Bari, Italy

Location

Universita di Bari Policinico I Clinical Ostetrica e Ginecologica

Bari, Italy

Location

Ospedale Fatebenefratelli

Benevento, Italy

Location

Ospedale Senatore Antonio Perrino

Brindisi, Italy

Location

Universita Cattolica del Sacro Cuore

Campobasso, Italy

Location

Ospedale A. Manzoni

Lecco, Italy

Location

Istituto Nazionale Tumori

Milan, Italy

Location

A.O. Univeristaria Policlinico

Modena, Italy

Location

Azienda Ospedaliera D. Cotugno

Napoli, 80131, Italy

Location

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

Napoli, 80131, Italy

Location

Università Federico II, Cattedra di Oncologia Medica

Napoli, Italy

Location

Ospedale Silvestrini

Perugia, Italy

Location

Ospedale Civile S. Spirito

Pescara, Italy

Location

A.O. S. Maria degli Angeli

Pordenone, Italy

Location

Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia

Roma, Italy

Location

A.O. di Udine S. Maria della Misericordia

Udine, Italy

Location

Related Publications (1)

• 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.

  PMID: 24582486 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Neurotoxicity Syndromes

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

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; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 17, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (28)