MITO-6: Capecitabine in Platinum Resistant Ovarian Cancer
This study has been completed.
Sponsor:
National Cancer Institute, Naples
Information provided by:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00403429
First received: November 22, 2006
Last updated: February 23, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer. |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute, Naples:
Primary Outcome Measures:
- objective response rate
- toxicity
| Estimated Enrollment: | 32 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403429
Locations
| Italy | |
| Clinica Malzoni, Reparto di Ginecologia Oncologica | |
| Avellino, AV, Italy, 83100 | |
| Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica | |
| Acquaviva delle Fonti, BA, Italy, 70021 | |
| IRCCS Oncologico Bari, Oncologia Medica | |
| Bari, BA, Italy, 70126 | |
| Ospedale Fatebenefratelli, U.O. di Oncologia | |
| Benevento, BN, Italy, 82100 | |
| Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia | |
| Catania, CT, Italy, 95126 | |
| IRCCS Casa Solllievo della Sofferenza | |
| San Giovanni Rotondo, FG, Italy | |
| Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia | |
| Mantova, MN, Italy, 46100 | |
| Ospedale Ramazzini, Day Hospital Oncologico | |
| Carpi, MO, Italy, 41012 | |
| Policlinico Universitario P. Giaccone | |
| Palermo, PA, Italy, 90100 | |
| Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico | |
| Palermo, PA, Italy, 90146 | |
| Ospedale S. Massimo, Day Hospital Oncologico | |
| Penne, PE, Italy, 65017 | |
| Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C | |
| Aviano, PN, Italy, 33081 | |
| Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia | |
| Pordenone, PN, Italy, 33170 | |
| Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica | |
| Vicenza, VI, Italy, 36100 | |
| Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C | |
| Napoli, Italy, 80131 | |
| Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B | |
| Napoli, Italy, 80131 | |
| Ospedale S. Giovanni Calibita Fatebenefratelli | |
| Roma, Italy, 00186 | |
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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00403429 History of Changes |
| Other Study ID Numbers: | MITO-6, EudraCT number 2006-001724-40 |
| Study First Received: | November 22, 2006 |
| Last Updated: | February 23, 2010 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by National Cancer Institute, Naples:
|
oral chemotherapy platinum resistant platinum refractory second line |
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 |
Capecitabine Fluorouracil Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013