Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00758732
• Other study ID #: CT/05.09
• Status: Terminated
• Phase: Phase 2
• First received: September 24, 2008
• Last updated: September 25, 2015
• Start date: October 2005
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athnes, Dep of Medical Oncology	Athens
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	Department of Medical Oncology, "Marika Iliadis" Hospital of Athens	Athens
Greece	Department of Medical Oncology, Air Forces Military Hospital of Athens	Athens
Greece	Medical Oncology Unit, 401 Military Hospital of Athens	Athens
Greece	University Hospital of Crete	Heraklion	Crete
Greece	State General Hospital of Larissa, Dep of Medical Oncology	Larissa
Greece	First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki
Greece	Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki	Thessaloniki
Greece	Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Toxicity profile		Toxicity assessment on each cycle	Yes
Secondary	Time to tumor progression		1 year	No
Secondary	Overall Survival		1 year	No