A Phase II Evaluation of Panitumumab and Gemcitabine as Treatment for Women With Recurrent Epithelial Ovarian Cancer.
Epithelial ovarian cancer (EOC) remains a leading cause of gynecologic cancer mortality in
women, with more than 22,000 deaths per year in the United States alone. Due to the lack of
effective screening strategies and subtle early symptoms, eighty percent of newly diagnosed
patients have disease that is advanced. Despite cytoreductive surgery and adjuvant
paclitaxel-based and platinum-based chemotherapy, 5-year survival rates continue to be less
than 40%. For patients who become resistant to the platinum compounds (defined as
progressive disease while on a platinum-based chemotherapy regimen (refractory) or within 6
months of completing a platinum-based chemotherapy regimen (resistant)),the outlook is
particularly poor, and often heralds multi-drug resistant disease.
At the present time, the management of ovarian cancer in the platinum refractory disease
state is limited to palliative intent. Patients with advanced, bulky tumors, poor
performance status and nutritional compromise are unlikely to respond to therapy and may be
best served by supportive care. The clinical management of refractory disease requires both
patience and persistence. A patient with platinum refractory disease is begun on one of the
agents with activity and an evaluation of response is made every 6-8 weeks of therapy. As
long as the patient shows no signs of disease progression, the therapy can be continued
unless there is unacceptable toxicity. When progressive disease is observed, another of the
list of available agents can be used. It is likely that patients will receive multiple
single agents during the chronic phase of their illness. Every effort should be made to
balance disease response with toxicity and quality of life.
Based on this rational, this trial will be conducted to evaluate the safety and efficacy of
panitumumab, a human antibody targeted to the EGF-R, and Gemcitabine, in treating women with
recurrent platinum-refractory/resistant EOC. Our aim is to determine the safety and
feasibility of gemcitabine and panitumumab therapy in this population and once completed, to
proceed with an efficacy study using an expanded cohort.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate, measured by RECIST criteria
Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.
Every 8 weeks while on-study
Carolyn McCourt, MD
Women & Infants' Hospital
United States: Food and Drug Administration
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