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

Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer

Intervention: Docetaxel (Drug); Carboplatin (Drug); Docetaxel (Drug); Liposomal doxorubicin (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
Christos Emmanouilides, MD, Principal Investigator, Affiliation: Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

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

Clinical Details

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

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

Primary outcome: Overall Response Rate

Secondary outcome:

Toxicity profile

Time to tumor progression

Overall Survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

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

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, Greece

University Hospital of Crete, Heraklion, Crete 71110, Greece

Additional Information

Starting date: October 2005
Last updated: May 20, 2011

Page last updated: August 23, 2015

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