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

Hellenic Oncology Research Group

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00750386

CT/07.07

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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