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

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00750386
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-20
• Last Update Posted: 2011-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Carboplatin	Paclitaxel/Carboplatin
1	Paclitaxel	Paclitaxel/Carboplatin

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose and the response rate	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

Name	Time	Method
Time to tumor progression	1 year
Toxicity profile	Toxicity assessment on each cycle

Trial Locations

Locations (12)

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

"IASO" General Hospital of Athnes, Dep of Medical Oncology; 🇬🇷 Athens, Greece

Department of Medical Oncology, "Marika Iliadis" Hospital of Athens; 🇬🇷 Athens, Greece

Medical Oncology Unit, 401 Military Hospital of Athens; 🇬🇷 Athens, Greece

First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas; 🇬🇷 Piraeus, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

Department of Medical Oncology, Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

State General Hospital of Larissa, Dep of Medical Oncology; 🇬🇷 Larissa, 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