Trial | NCT00758732  Report issue

Title

Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma
A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    34
This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months
The second-line treatment in advanced ovarian cancer has been proved effective in prolonging overall survival and improving quality of life. In patients with platinum-sensitive ovarian cancer (relapsed disease after 6 months from the end of first line chemotherapy) the combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the combination platinum-based chemotherapy may well be associated with a survival benefit in patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx) docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be active in platinum-sensitive disease.
Study Started
Oct 31
2005
Primary Completion
Mar 31
2011
Study Completion
Mar 31
2011
Last Update
Sep 28
2015
Estimate

Drug Docetaxel

Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

  • Other names: Taxotere

Drug Carboplatin

Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

Drug Docetaxel

Docetaxel at the dose of 40mg/m2 over a 60 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.

  • Other names: Taxotere

Drug Liposomal doxorubicin

Liposomal doxorubicin at the dose of 20 mg/m2 over a 90 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.

  • Other names: Caelyx

1 Experimental

Docetaxel/carboplatin

2 Experimental

Docetaxel/Caelyx

Criteria 

Inclusion Criteria:

Histologically confirmed ovarian cancer
Stage IIIB/IV
Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval > 6 months
Presence of two-dimensional measurable disease.
Life expectancy of more than 3 months.
Age ≥ 18 years.
Performance status (WHO) 0-2
Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
Adequate liver (Bilirubin<1.5 times upper limit of normal and SGOT/SGPT<2 times upper limit of normal) and renal function (creatinine<2mg/dl)
Informed consent

Exclusion Criteria:

Pregnant or nursing
Psychiatric illness or social situation that would preclude study compliance'
Other concurrent uncontrolled illness
Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Other concurrent investigational agents
No Results Posted