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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00758732

Enrollment

Registered

2008-09-25

Start date

2005-10-31

Completion date

2011-03-31

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Cancer, Ovarian cancer, Chemotherapy, Docetaxel, Carboplatin, Pegylated doxorubicin, Platinum sensitive

Brief summary

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

Detailed description

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.

Interventions

DRUGDocetaxel

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

DRUGCarboplatin

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

DRUGLiposomal 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall Response Rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary

Measure	Time frame
Toxicity profile	Toxicity assessment on each cycle
Time to tumor progression	1 year
Overall Survival	1 year

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026