Clinical trial NCT00750386: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Keywords: Cancer
Ovarian cancer
Dose-dense chemotherapy
Lead sponsor: Hellenic Oncology Research Group
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2008-09-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Determine the maximum tolerated dose and the response rate
timeFrame: Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes:
measure: Toxicity profile
timeFrame: Toxicity assessment on each cycle
measure: Time to tumor progression
timeFrame: 1 year
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University Hospital of Crete
state: Crete
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis, Dep of Medical Oncology
city: Athens
country: Greece
facility: "IASO" General Hospital of Athnes, Dep of Medical Oncology
city: Athens
country: Greece
facility: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
city: Athens
country: Greece
facility: Department of Medical Oncology, "Marika Iliadis" Hospital of Athens
city: Athens
country: Greece
facility: Department of Medical Oncology, Air Forces Military Hospital of Athens
city: Athens
country: Greece
facility: Medical Oncology Unit, 401 Military Hospital of Athens
city: Larissa
country: Greece
facility: State General Hospital of Larissa, Dep of Medical Oncology
city: Piraeus
country: Greece
facility: First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas
city: Thessaloniki
country: Greece
facility: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
city: Thessaloniki
country: Greece
facility: Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
city: Thessaloniki
country: Greece
facility: Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
Study officials:
affiliation: Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
name: Christos Emmanouilides, MD
role: PRINCIPAL_INVESTIGATOR
References: