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Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750386
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : May 23, 2011
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Drug: Paclitaxel Drug: Carboplatin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
Study Start Date : January 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: 1
Drug: Paclitaxel
175 mg/m2, I.V, every 2 weeks

Drug: Carboplatin
Carboplatin AUC, I.V, 5 every 2 weeks

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Toxicity profile [ Time Frame: Toxicity assessment on each cycle ]
  2. Time to tumor progression [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00750386

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University Hospital of Crete
Heraklion, Crete, Greece, 71110
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
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
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Principal Investigator: Christos Emmanouilides, MD Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
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Responsible Party: Christos Emmanouilides, Hellenic Oncology Research Group Identifier: NCT00750386    
Other Study ID Numbers: CT/07.07
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011
Keywords provided by Hellenic Oncology Research Group:
Ovarian cancer
Dose-dense chemotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action