Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence and to Prolong the Platinum Free Interval - Full Text View

Sponsored by:	National Cancer Institute, Naples
Information provided by:	National Cancer Institute, Naples
ClinicalTrials.gov Identifier:	NCT00657878

Purpose

This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval (PFI) with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.

Condition	Intervention	Phase
Ovarian Cancer	Drug: stealth liposomal doxorubicin Drug: carboplatin Drug: paclitaxel	Phase III

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
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

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:

overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

progression free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
quality of life [ Time Frame: at baseline and after 3rd and 6th cycles of chemotherapy ] [ Designated as safety issue: No ]
response rate [ Time Frame: after 3rd and 6th cycles of chemotherapy ] [ Designated as safety issue: No ]
toxicity [ Time Frame: at each cycle of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental stealth liposomal doxorubicin followed at a later progression by carboplatin and paclitaxel	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 beginning after progression Drug: paclitaxel paclitaxel 175 mg/m2 IV day 1 every 21 days beginning after progression
Arm B: Active Comparator carboplatin and paclitaxel followed at a later progression by stealth liposomal doxorubicin	Drug: carboplatin carboplatin AUC 5 IV day 1 every 21 days Drug: paclitaxel paclitaxel 175 mg/m2 IV day 1 every 21 days Drug: stealth liposomal doxorubicin stealth liposomal doxorubicin 40 mg/m2 IV day 1 every 28 days after disease progression

Detailed Description:

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 sequence of stealth liposomal doxorubicin followed at a later progression by carboplatin/paclitaxel is superior to the inverse sequence of treatment (carboplatin/paclitaxel followed at a later progression by stealth liposomal doxorubicin).

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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 2
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657878

Contacts

Contact: Sandro Pignata, M.D., Ph.D.	+39 081 5903637	sandro.pignata@fondazionepascale.it
Contact: Francesco Perrone, M.D., Ph.D.	+39 081 5903571	francesco.perrone@uosc.fondazionepascale.it

Locations

Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico	Recruiting
Napoli, Italy, 80131

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:	Alessandro Morabito, M.D.,	National Cancer Institute, Naples
Principal Investigator:	Ciro Gallo, M.D., Ph.D.	Second University of Naples

More Information

Responsible Party:	National Cancer Institute Naples ( Sandro Pignata )
Study ID Numbers:	MITO-8, EudraCT number: 2008-001755-22
Study First Received:	April 8, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00657878
Health Authority:	Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:

platinum free interval
chemotherapy

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Carboplatin

Ovarian Diseases
Recurrence
Doxorubicin
Genital Diseases, Female
Paclitaxel
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009