Know Cancer

or
forgot password

Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer


Phase 3
N/A
75 Years
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer


Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. The
high mortality rate is due to the late diagnosis of this malignancy that often develops
without symptoms, as well as to limited results in treatment of the disease. Patients may
respond well initially to chemotherapy, but the vast majority of patients will experience a
progression of the disease. The poor long term results in the standard treatment available
today for first-line chemotherapy of ovarian cancer make research into new, more beneficial
treatment strategies necessary. The proven efficacy of liposomal doxorubicin in second line
treatment, where it is the first drug to have shown some significant benefit in terms of
survival, and the possibility of easily combining it with full doses and normal use of
carboplatin, encourages the testing of the effectiveness of the combination of carboplatin
and liposomal doxorubicin in first line treatment.

Patients enrolled into this study will be randomly assigned to one of two treatment groups:

· Standard therapy consisting of 6 cycles of chemotherapy:

- carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND

- paclitaxel 175 mg/m2 given intravenously on day 1 every 3 weeks

OR

· Experimental therapy consisting of 6 cycles of chemotherapy:

- carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND

- liposomal doxorubicin 30 mg/m2 given intravenously on day 1 every 3 weeks


Inclusion Criteria:



- Cytologic / histologic diagnosis of stage Ic-IV ovarian cancer

- Indication for chemotherapy treatment

- Age 75 years or less

- Life expectancy of at least 3 months

Exclusion Criteria:

- Previous or concomitant malignant neoplasia (not including basocellular or
spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided
they are being adequately treated)

- Performance status (ECOG) > 2

- Previous chemotherapy treatment

- Heart disease (heart failure, myocardial heart attack within 6 months prior to
randomization, atrioventricular block of any degree, serious arrhythmia)

- Leukocytes < 4000/mm3, neutrophils < 2000/mm3, platelets < 100000/mm3

- Impaired renal function (creatinine > 1.25 times the upper normal limit) or liver
function (SGOT or SGPT > 1.25 times the upper normal limit)

- Present or suspected hemorrhagic syndromes

- Uncooperative and/or unreliable patients

- Patient's inability to access the center

- Refusal of informed consent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

at 2 years

Safety Issue:

No

Principal Investigator

Sandro Pignata, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Naples

Authority:

Italy: Ethics Committee

Study ID:

MITO-2

NCT ID:

NCT00326456

Start Date:

January 2003

Completion Date:

December 2013

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • chemotherapy
  • first-line
  • Ovarian Neoplasms

Name

Location