Oncology Medical News about platinum-resistant ovarian cancer;primary peritoneal carcinomatosis

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Activity of 2 methoxyestradiol (Panzem® NCD) in advanced, platinum-resistant ovarian cancer and primary peritoneal carcinomatosis: A Hoosier Oncology Group trial
Gynecologic Oncology, 09/15/09

Mateia D et al. – The NCD formulation of 2ME2 is well tolerated in patients with heavily pretreated EOC. Few of these heavily pretreated patients had sustained stable disease.

Methods

Eligible patients had relapsed, platinum-resistant or refractory EOC with measurable or detectable disease
No limit on the number of prior treatment regimens
2ME2 NCD 1000 mg orally four times daily (q.i.d.) was administered continuously during 4 week cycles
Primary endpoint was objective response rate (ORR).
Secondary endpoints=assessment of toxicity, rate of clinical benefit defined as the number of patients experiencing an objective response
Additional secondary endpoints=mean change in CA-125, progression-free survival (PFS), and pharmacokinetic analyses of 2ME2

Results

18 patients
Median age was 65.5 (range 40–73)
Patients had received a median of five prior treatments
Adverse events were fatigue (78%), nausea (78%), diarrhea (39%), neuropathy (50%), edema (39%), and dyspnea (44%), the majority being grade 1–2
7 patients had SD as best response
2 patients had SD for greater than 12 months
The rate of clinical benefit was 31.3%
Fairly stable plasma levels of 2ME2 ranging within the predicted therapeutic window observed

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