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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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