Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas - Full Text View

Purpose

This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Paclitaxel Drug: Carboplatin	Phase I Phase II

MedlinePlus related topics:

Cancer Ovarian Cancer

ChemIDplus related topics:

Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Determine the maximum tolerated dose and the response rate [ Time Frame: Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Toxicity profile [ Time Frame: Toxicity assessment on each cycle ] [ Designated as safety issue: Yes ]
Time to tumor progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Paclitaxel/Carboplatin	Drug: Paclitaxel 175 mg/m2, I.V, every 2 weeks Drug: Carboplatin Carboplatin AUC, I.V, 5 every 2 weeks

Detailed Description:

Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy
Patients have to be chemotherapy naive
Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination
Age >18 years.
Performance status (WHO) 0-2
Life expectancy of at least three months.
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
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750386

Contacts


Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr

Contact: Eva Maragkoudaki	+302810392857	dorachat@med.uoc.gr

Locations


Greece
	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Recruiting
	Athens, Greece
	Contact: Nikoleta Karkatzou +302106457968 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Aris Polyzos, MD
	"IASO" General Hospital of Athnes, Dep of Medical Oncology	Recruiting
	Athens, Greece
	Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Stelios Giassas, MD
	State General Hospital of Larissa, Dep of Medical Oncology	Recruiting
	Larissa, Greece
	Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Athanasios Athanasiadis, MD
	Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki	Recruiting
	Thessaloniki, Greece
	Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
	Contact: Spyros Georgiadis +302810392857 secretary@horg.gr
	Principal Investigator: Christos Emmanouilides, MD
	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Recruiting
	Alexandroupolis, Greece
	Contact: Nikoleta Karkatzou, MD +302106457968 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Stelios Kakolyris, MD
	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Recruiting
	Thessaloniki, Greece
	Contact: Nikoleta Karkatzou +302106457968 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Ioannis Boukovinas, MD
	Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki	Recruiting
	Thessaloniki, Greece
	Contact: Nikoleta Karkatzou, MD +302106448666 secretary@med.uoc.gr
	Contact: Spyros Georgiadis +302106457968 secretary@med.uoc.g
	Principal Investigator: Paris Makrantonakis, MD
	Department of Medical Oncology, "Marika Iliadis" Hospital of Athens	Recruiting
	Athens, Greece
	Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Nikos Malamos, MD
	First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas	Recruiting
	Piraeus, Greece
	Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Nikos Ziras, MD
	Medical Oncology Unit, 401 Military Hospital of Athens	Recruiting
	Athens, Greece
	Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Charalambos Christophillakis, MD
	Department of Medical Oncology, Air Forces Military Hospital of Athens	Recruiting
	Athens, Greece
	Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
	Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
	Principal Investigator: Nikos Kentepozidis, MD

Greece, Crete
	University Hospital of Crete	Recruiting
	Heraklion, Crete, Greece, 71110
	Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
	Contact: Eva Maragkoudaki +302810392987 dorachat@med.uoc.gr
	Principal Investigator: Antonia Kalikaki, MD

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators


Principal Investigator:	Christos Emmanouilides, MD	Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

More Information

Responsible Party:	Hellenic Oncology Research Group ( Christos Emmanouilides )
Study ID Numbers:	CT/07.07
First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750386
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Cancer

Ovarian cancer

Dose-dense chemotherapy

Study placed in the following topic categories:

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Carboplatin

Ovarian Diseases

Ovarian epithelial cancer

Carcinoma

Genital Diseases, Female

Paclitaxel

Endocrinopathy

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00750386