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MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
capecitabine
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring oral chemotherapy, platinum resistant, platinum refractory, second line

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Cytologic or histologic diagnosis of relapsed ovarian cancer
  • Refractory or resistant to platinum salts disease
  • Age < 75 years
  • At least one measurable lesion (³ 20 mm with conventional techniques or ³ 10 mm with spiral CT scan)
  • Life expectancy of at least 3 months
  • Written informed consent

Exclusion Criteria:

  • Previous or concomitant malignant neoplasia within 5 years prior to basal evaluation (excluding adequately treated basocellular or spinocellular skin carcinoma or in situ carcinoma of the uterine cervix).
  • Performance Status (ECOG) ³ 3
  • Previous chemotherapy treatment with capecitabine
  • More than 3 lines of chemotherapy
  • Heart disease (heart failure, heart attack during the 6 months prior to the trial, atrioventricular block of any degree, serious arrhythmia)
  • Leukocytes < 4000/mm3, platelets < 100000/mm3
  • Modifications of renal function (Creatinine ³ 1.25 times the upper normal limit) or liver function (SGOT or SGPT ³ 1.25 times the upper normal limit)
  • Present or suspected haemorrhagic syndromes
  • Uncooperative and/or unreliable patients
  • Patients' inability to access the centre

Sites / Locations

  • Clinica Malzoni, Reparto di Ginecologia Oncologica
  • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
  • IRCCS Oncologico Bari, Oncologia Medica
  • Ospedale Fatebenefratelli, U.O. di Oncologia
  • Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
  • IRCCS Casa Solllievo della Sofferenza
  • Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
  • Ospedale Ramazzini, Day Hospital Oncologico
  • Policlinico Universitario P. Giaccone
  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
  • Ospedale S. Massimo, Day Hospital Oncologico
  • Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
  • Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
  • Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
  • Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
  • Ospedale S. Giovanni Calibita Fatebenefratelli

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capecitabine

Arm Description

Outcomes

Primary Outcome Measures

objective response rate
toxicity

Secondary Outcome Measures

Full Information

First Posted
November 22, 2006
Last Updated
January 13, 2016
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00403429
Brief Title
MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer
Official Title
Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer.
Detailed Description
Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. Standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are frequent and 5-year survival is only 20%. Current therapies for second line treatment of recurrence in patients who have platinum refractory (who experienced progression of the disease during first line platinum based therapy) or platinum resistant (who experienced a recurrence of the disease within 6 months of completing platinum based therapy)ovarian cancer are limited. Capecitabine, an oral chemotherapy already used in colon and breast cancers, has shown some promise in early clinical trials for treating recurrent ovarian cancer. Patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14 every 21 days for up to 6 cycles, depending on response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
oral chemotherapy, platinum resistant, platinum refractory, second line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
capecitabine
Primary Outcome Measure Information:
Title
objective response rate
Time Frame
6 months
Title
toxicity
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cytologic or histologic diagnosis of relapsed ovarian cancer Refractory or resistant to platinum salts disease Age < 75 years At least one measurable lesion (³ 20 mm with conventional techniques or ³ 10 mm with spiral CT scan) Life expectancy of at least 3 months Written informed consent Exclusion Criteria: Previous or concomitant malignant neoplasia within 5 years prior to basal evaluation (excluding adequately treated basocellular or spinocellular skin carcinoma or in situ carcinoma of the uterine cervix). Performance Status (ECOG) ³ 3 Previous chemotherapy treatment with capecitabine More than 3 lines of chemotherapy Heart disease (heart failure, heart attack during the 6 months prior to the trial, atrioventricular block of any degree, serious arrhythmia) Leukocytes < 4000/mm3, platelets < 100000/mm3 Modifications of renal function (Creatinine ³ 1.25 times the upper normal limit) or liver function (SGOT or SGPT ³ 1.25 times the upper normal limit) Present or suspected haemorrhagic syndromes Uncooperative and/or unreliable patients Patients' inability to access the centre
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Pignata, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Malzoni, Reparto di Ginecologia Oncologica
City
Avellino
State/Province
AV
ZIP/Postal Code
83100
Country
Italy
Facility Name
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
City
Acquaviva delle Fonti
State/Province
BA
ZIP/Postal Code
70021
Country
Italy
Facility Name
IRCCS Oncologico Bari, Oncologia Medica
City
Bari
State/Province
BA
ZIP/Postal Code
70126
Country
Italy
Facility Name
Ospedale Fatebenefratelli, U.O. di Oncologia
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia
City
Catania
State/Province
CT
ZIP/Postal Code
95126
Country
Italy
Facility Name
IRCCS Casa Solllievo della Sofferenza
City
San Giovanni Rotondo
State/Province
FG
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
City
Mantova
State/Province
MN
ZIP/Postal Code
46100
Country
Italy
Facility Name
Ospedale Ramazzini, Day Hospital Oncologico
City
Carpi
State/Province
MO
ZIP/Postal Code
41012
Country
Italy
Facility Name
Policlinico Universitario P. Giaccone
City
Palermo
State/Province
PA
ZIP/Postal Code
90100
Country
Italy
Facility Name
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Ospedale S. Massimo, Day Hospital Oncologico
City
Penne
State/Province
PE
ZIP/Postal Code
65017
Country
Italy
Facility Name
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia
City
Pordenone
State/Province
PN
ZIP/Postal Code
33170
Country
Italy
Facility Name
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
City
Vicenza
State/Province
VI
ZIP/Postal Code
36100
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Fatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19266200
Citation
Pisano C, Morabito A, Sorio R, Breda E, Lauria R, Gebbia V, Scaltriti L, Scalone S, Zagonel V, Greggi S, Beneduce G, Losito S, Gallo C, Di Maio M, Forestieri V, Pignata S. A phase II study of capecitabine in the treatment of ovarian cancer resistant or refractory to platinum therapy: a multicentre Italian trial in ovarian cancer (MITO-6) trial. Cancer Chemother Pharmacol. 2009 Oct;64(5):1021-7. doi: 10.1007/s00280-009-0958-0. Epub 2009 Mar 6.
Results Reference
result

Learn more about this trial

MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer

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