Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Washington University School of Medicine
With
Sanofi
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed newly diagnosed Stage III/IV epithelial ovarian or primary peritoneal carcinoma at time of initial diagnosis
Treatment must start within 8 weeks of surgery
Subjects may be measurable per RECIST criteria or evaluable for disease response by CA125. Evaluable CA 125 levels are defined as an elevated CA125 pre operatively which either remains elevated post-operatively or normalizes after surgery
No prior chemotherapy or radiation therapy
Age ≥ 18
Performance Status must be ≤ 2 (ECOG)
Peripheral neuropathy: must be ≤ grade 1
Hematologic (minimal values)
* Absolute neutrophil count ≥ 1,500/mm3
* Hemoglobin ≥ 8.0 g/dl
* Platelet count ≥ 100,000/mm3
Hepatic
\*Total Bilirubin ≤ ULN
AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
You may not be if
Renal: Creatinine (serum) less than or equal to 1.5 ULN, CTC grade 1.
Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
PT/PTT ≤ 1.5 x's ULN
Patients with a history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80.
Women who are pregnant or breast-feeding.
Patients who have signs of infection or who have not recovered from the effects of recent surgery
Patients with a performance status of 3 or 4
Patients with a second malignancy within past 5 years other than non-melanoma skin carcinoma.
Patients who have received prior myelosuppressive chemotherapy or XRT.
Clareo Health | Carboplatin Plus Docetaxel With Day 2 Pegylated G-CSF (Neulasta®) in Patients With Advanced Stage Ovarian Carcinoma
