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

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00750386
First received: September 9, 2008
Last updated: May 20, 2011
Last verified: May 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma

Resource links provided by NLM:


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
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, 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
"IASO" General Hospital of Athnes, Dep of Medical Oncology
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
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Thessaloniki, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
Thessaloniki, Greece
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

No publications provided

Responsible Party: Christos Emmanouilides, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00750386     History of Changes
Other Study ID Numbers: CT/07.07
Study First Received: September 9, 2008
Last Updated: May 20, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Cancer
Ovarian cancer
Dose-dense chemotherapy

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 28, 2014