Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas
This study has been completed.
Sponsor:
Hellenic Oncology Research Group
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
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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
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 May 19, 2013