advanced or recurrent carcinosarcoma
Conditions
Interventions
Paclitaxel 175 mg/m2 was delivered over three hours followed by carboplatin dosed to an area under the serum concentration-time curve (AUC) = 6 intravenously over 30 minutes, on day 1, every 3 weeks (
Sponsors
Gynecology, Tohoku University Hospital
Japanese Uterine Sarcoma Group and Tohoku Gynecologic Cancer Unit
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Eligible patients had histologically confirmed, advanced stage III, IV, or recurrent CS with a measureable target lesion of ≥ 20 mm when measured by computed tomography (CT) and magnetic resonance imaging, or ≥ 10mm when measured by spiral CT. Patients had to have at least one target lesion to assess response on this protocol as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria . Two gynecologic pathologists performed a pathological slide review of the primary malignancy for all patients. Patients of childbearing potential had to have a negative serum pregnancy test before entry onto the study and had to be practicing an effective form of contraception. A minimum ECOG performance status of 0 to 2, granulocytes ≥ 1500/microL, platelets ≥ 100,000/microL, serum creatinine ≤ 1.5 X institutional upper limit of normal (ULN), adequate liver function with bilirubin ≤ 1.5 X institutional ULN, and AST and alkaline phosphatase ≤ 2.5 X the institutional ULN were also required. Patients were to have recovered from previous treatments and have no evidence of infection. Patients with neuropathy (sensory or motor) grade ≥ 1, according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 were excluded. Patients provided written informed consent consistent with institutional review board regulations before study entry.
Exclusion criteria
Exclusion criteria: Patients with prior cytotoxic chemotherapy were ineligible. Patients with a history of another invasive malignancy within the previous five years other than a non-melanoma skin cancer were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall Survival Adverse events | — |
Countries
Japan
Contacts
Public ContactTadao Takano
Tohooku University Hospital Gynecology
Outcome results
None listed