To be considered for enrolment you must have:
Inclusion criteria
Disease type
| |
(a) |
histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin; |
| |
(b) |
recurrent or persistent advanced disease; |
| |
(c) |
have measurable disease by CT |
Treatment response history
| |
(d) |
undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded to the first of those courses of therapy; |
| |
(e) |
shown disease relapse within 6 months of completion of the second or greater course of platinum therapy using a 2- or 3-weekly regimen and |
| |
(f) |
have a platinum-free interval of no greater than 6 months at the time of enrollment; |
Treatment history
| |
(g) |
can have any number of previous courses of platinum therapy or non-platinum therapy, providing that (f) applies; |
Clinical status
| |
(h) |
be considered likely to survive at least 3 months; |
| |
(i) |
have a Karnofsky Performance Score of at least 60%; |
| |
(j) |
have adequate physiological function without evidence of major organ dysfunction as evidenced by a serum creatinine  1.5 mg/dl, serum transaminase levels 3 x the upper limit of normal (ULN) for the reference laboratory, and a bilirubin level ULN; |
| |
(k) |
have adequate hematological function defined by platelets > 100,000/ mm3, WCC > 3,000/mm3, neutrophils > 1,500 /mm3, hemoglobin  8.0 g/dl; |
Other
| |
(l) |
be aged 18; and |
| |
(m) |
be able to understand the risks and benefits of the study and give written informed consent to participation. |
Exclusion criteria
Patients presenting with any of the following will not be included in the study:
| |
a) |
patients with mucinous or clear cell histological types of ovarian cancer; |
| |
b) |
patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy; |
| |
c) |
patients with active infection; |
| |
d) |
patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.); |
| |
e) |
patients with a history of chronic active hepatitis or cirrhosis; |
| |
f) |
patients with HIV; |
| |
g) |
patients with active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks; |
| |
h) |
patients who have not recovered from the acute effects of any prior anti-neoplastic therapy; and |
| |
i) |
patients with known hypersensitivity to platinum drugs. |
» Do I meet the criteria?
