Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval (MITO-8)
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| ClinicalTrials.gov Identifier: NCT00657878 |
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Recruitment Status : Unknown
Verified October 2015 by National Cancer Institute, Naples.
Recruitment status was: Active, not recruiting
First Posted : April 14, 2008
Last Update Posted : October 29, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer | Drug: stealth liposomal doxorubicin Drug: carboplatin Drug: paclitaxel Drug: Topotecan Drug: Gemcitabine | Phase 3 |
Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen.
Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients.
This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 215 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy. |
| Study Start Date : | November 2008 |
| Estimated Primary Completion Date : | July 2016 |
| Estimated Study Completion Date : | June 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: non platinum based chemotherapy
a non platinum based therapy (corresponding to stealth liposomal doxorubicin, or topotecan, or gemcitabine,or any other drug approved in clinical practice for the treatment of patients with ovarian cancer after previous platinum-based chemotherapy) followed by a platinum based chemotherapy at disease progression
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Drug: stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days Drug: carboplatin carboplatin AUC 5 IV day 1 every 21 days Drug: paclitaxel paclitaxel 175 mg/m2 IV day 1 every 21 days Drug: Topotecan dosing and schedule according to Institutional guidelines Drug: Gemcitabine 1000 mg/m2 on days 1,8,15 every 28 days |
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Active Comparator: platinum based chemotherapy
platinum based chemotherapy (corresponding to the combination of carboplatin + paclitaxel, or carboplatin + gemcitabine for patients with significant but lower than grade 3 neuropathy at baseline) followed by a non platinum based chemotherapy at disease progression
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Drug: stealth liposomal doxorubicin
stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days Drug: carboplatin carboplatin AUC 5 IV day 1 every 21 days Drug: paclitaxel paclitaxel 175 mg/m2 IV day 1 every 21 days Drug: Topotecan dosing and schedule according to Institutional guidelines Drug: Gemcitabine 1000 mg/m2 on days 1,8,15 every 28 days |
- overall survival [ Time Frame: 18 months ]
- progression free survival [ Time Frame: 18 months ]
- changes in quality of life [ Time Frame: 9 months ]quality of life is measured at baseline and at 3 months and 6 months after patient begins study
- number of objective responses [ Time Frame: 6 months ]
- worst grade toxicity for each patient [ Time Frame: 6 months ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological diagnosis of ovarian cancer
- Disease recurrence between 6 and 12 months after a first-line platinum based therapy
- Indication for chemotherapy, but no more than 2 previous lines of previous therapy
- Life expectancy of more than 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)
- ECOG Performance Status at least 3
- Previous treatment with stealth liposomal doxorubicin
- Residual peripheral neuropathy Grade 3 or higher
- 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 no greater than 1.25 x normal values) or liver function (ALT or AST no greater than 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
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): NCT00657878
Show 40 study locations
| 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" |
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT00657878 |
| Other Study ID Numbers: |
MITO-8 2008-001755-22 ( EudraCT Number ) |
| First Posted: | April 14, 2008 Key Record Dates |
| Last Update Posted: | October 29, 2015 |
| Last Verified: | October 2015 |
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platinum free interval chemotherapy |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Recurrence Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Disease Attributes Pathologic Processes Gemcitabine Paclitaxel Carboplatin Doxorubicin Liposomal doxorubicin Topotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic |