A pilot study of gemcitabine (g), oxaliplatin (o), cetuximab (c) for locally advanced or metastatic pancreatic cancer

Abstract

15510 Background: Little progress has been made in the treatment of advanced pancreatic cancer (PC). Preclinical data suggest synergism between a platinum + G, and G + C. The combination of G and erlotinib is a standard. The combination of G and platinums is associated with higher RR and PFS to G alone. Methods: The study primary endpoint was to determine the progression free survival (PFS) of GOC in patients with locally advanced or metastatic pancreatic cancer. It was expected that GOC would extend PFS from 5.8 months to 7.54 months (relative increase of 30%). Chemotherapy naïve patients with locally advanced (LA) or metastatic (M) PC with PS 0–2 and good organ function were eligible. Treatment: G, 1000 mg/m2 over 100 minutes and C, at a loading dose of 400 mg/m2 on day 1 (250 mg/m2 on day 8 and subsequent cycles), and O,100 mg/m2 on day two, every two weeks (one cycle). Patients were treated until disease progression, intolerable toxicity, or patient refusal. Efficacy evaluation was performed every 4 cycles. Results: A total of 41 evaluable patients were enrolled from June 2006 to July 2007. Median age was 62 years, (range: 44–82). Male/female: 19/22. Twenty patients (48.8%) had metastatic disease. Median PFS time was 6.9 months (95% CI=3.9–9.2). Median PFS in LA patients was 7.5 months vs. 4.5 months in M patients. Confirmed RR= 24% (95% CI=12–40%), with one (2.4%) CR and 9 (22%) PR. Clinical benefit rate (CR, PR and SD) was 75, 6% (95% CI=59.7–87.6%). One year survival was 53% (95% CI=30–71%). Median OS was 6.5 months in the M group and not reached yet in the LA group. 1-year survival for LA: 75% (95% CI=37–92%), M: 33% (95% CI=7–62%). Most frequent grade 3/4 AEs (≥ 10% of patients) included neutropenia, infection, liver enzyme elevation, fatigue, diarrhea, peripheral neuropathy, hypokalemia and thrombosis. Conclusions: GOC is an active combination with a favorable toxicity profile. The study did not meet its primary endpoint. Updated information on the primary and secondary endpoints and correlative studies on available tumor specimens will be presented. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration ImClone Systems Incorporated, Lilly Oncology, Pfizer Oncology, sanofi-aventis