Phase II study of sequential paclitaxel (P) and bryostatin-1 (Bryo) for patients with advanced pancreatic cancer (P 5624)

4223 Background: Bryo, a macrocyclic lactone, modulates protein kinase C and enhances P's ability to induce apoptosis. Enhanced apoptosis induction is only seen when P precedes bryo (Koutcher, Clin Cancer Res. 6: 1498). In the phase I study of sequential P followed by bryo, activity in pancreas cancer was seen; myalgias were dose limiting (Kaubisch, Proc ASCO, 2000, Abstr. 900). Methods: Patients (pts) with pathologically confirmed, locally advanced or metastatic adenocarcinoma of the pancreas were eligible. Prior treatment was permitted, prior taxane exposure was not. P was given at 90 mg/m2 over 1 hour day 1, followed by bryo 25 mcg/m2 over 1 hour on day 2, weekly x 3, followed by one week rest (28 day cycles). CT's were performed every 2 cycles. Results: 20 pts (mean age 58, 21–82) received an average of 2.6 cycles (0–10, median 2). Five pts are not evaluable for response (2 early deaths: (fungal sepsis, liver abscess); one pt withdrew, one was never treated, one ineligible). One pt (6%) achieved a min...