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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Cancer, Ovarian cancer, Dose-dense chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Paclitaxel/Carboplatin

Outcomes

Primary Outcome Measures

Determine the maximum tolerated dose and the response rate

Secondary Outcome Measures

Toxicity profile
Time to tumor progression

Full Information

First Posted
September 9, 2008
Last Updated
May 20, 2011
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00750386
Brief Title
Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas
Official Title
Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Cancer, Ovarian cancer, Dose-dense chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Paclitaxel/Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m2, I.V, every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC, I.V, 5 every 2 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Toxicity profile
Time Frame
Toxicity assessment on each cycle
Title
Time to tumor progression
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos Emmanouilides, MD
Organizational Affiliation
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athnes, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
Department of Medical Oncology, "Marika Iliadis" Hospital of Athens
City
Athens
Country
Greece
Facility Name
Department of Medical Oncology, Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Medical Oncology Unit, 401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa
Country
Greece
Facility Name
First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece
Facility Name
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

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

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