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

Ovarian Cancer Clinical Trial

Official title:

Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750386
• Other study ID #: CT/07.07
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2008
• Last updated: May 20, 2011
• Start date: January 2008
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Paclitaxel
175 mg/m2, I.V, every 2 weeks
• Carboplatin
Carboplatin AUC, I.V, 5 every 2 weeks

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athnes, Dep of Medical Oncology	Athens
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	Medical Oncology Unit, 401 Military Hospital of Athens	Athens
Greece	University Hospital of Crete	Heraklion	Crete
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	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki
Greece	Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki	Thessaloniki
Greece	Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Toxicity profile		Toxicity assessment on each cycle	Yes
Secondary	Time to tumor progression		1 year	No