Panitumumab and Gemcitabine in Relapsed Ovarian Cancer (PanGem)
This is a study to find out if the study drug, panitumumab, when given with gemcitabine works in treating ovarian cancer and to find out what side effects occur when they are given together.
Fallopian Tube Cancer
Primary Peritoneal Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Panitumumab and Gemcitabine as Treatment for Women With Recurrent Epithelial Ovarian Cancer.|
- Overall response rate, measured by RECIST criteria [ Time Frame: Every 8 weeks while on-study ] [ Designated as safety issue: No ]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 If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.
- Adverse Events, measured by Active Version of the NCI Common Toxicity Criteria [ Time Frame: before each cycle of treatment until resolution ] [ Designated as safety issue: Yes ]Adverse events (AEs) will be recorded during the duration of the trial, whether or not the events are considered related to medication. All AEs considered to be related to trial therapy will be followed for resolution, including into the post-treatment period.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Experimental: Panitumuab and Gemcitabine||
Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
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.
|Contact: Carolyn M McCourt, MDfirstname.lastname@example.org|
|Contact: Carol Berk, RNemail@example.com|
|United States, Rhode Island|
|Women & Infants' Hospital||Recruiting|
|Providence, Rhode Island, United States, 02905|
|Contact: Carol Berk, RN 401-274-1122 firstname.lastname@example.org|
|Contact: Wendy Young, RN 401-274-1122 email@example.com|
|Principal Investigator:||Carolyn McCourt, MD||Women & Infants' Hospital|