Phase II evaluation of fluorouracil and recombinant alpha-2a-interferon in previously untreated patients with pancreatic adenocarcinoma.
BACKGROUND
Based on initial encouraging results of the combination of 5-fluorouracil (5-FU) with recombinant alpha-2a-interferon (r alpha-2a-IFN) in the treatment of advanced colorectal carcinomas, a clinical trial was conducted using 5-FU with r alpha-2a-IFN in 49 patients with advanced pancreatic adenocarcinoma.


METHODS
Forty-nine patients who had bidimensionally measurable disease and had not been treated previously with chemotherapy were entered in the trial. Starting on day 1, 5-FU was administered as a continuous infusion at a dose of 750 mg/m2/day for 5 consecutive days. Starting on day 12, it was administered as an intravenous bolus of 750 mg/m2 a week for 7 weeks. The r alpha-2a-IFN was administered subcutaneously at a dose of 9 x 10(6) units three times a week during weeks 1-8.


RESULTS
Of the 46 patients evaluable for response, none had a complete response, and two had partial responses that lasted 14 and 28 weeks. The overall response rate was 4% (95% confidence interval, 1-15%). Fourteen patients had minor responses (median duration of response, 12 weeks). The median length of survival of all patients enrolled in this trial was 22 weeks. Grade 3-4 toxicities included oral mucositis in 19 patients, granulocytopenia in 16, fatigue in 8, and diarrhea in 3. One patient had severe ataxia and leg weakness. Another died of neutropenic sepsis.


CONCLUSIONS
This regimen had significant toxicity and little evidence of therapeutic activity against advanced pancreatic carcinoma.
Pazdur
R
R
Section of Gastrointestinal Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030.
Ajani
J J
JJ
Abbruzzese
J L
JL
Belt
R J
RJ
Dakhil
S R
SR
Dubovsky
D
D
Graham
S
S
Pilat
S
S
Winn
R
R
Levin
B
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000380:Agranulocytosis / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011994:Recombinant Proteins; D013280:Stomatitis / Q000139:chemically induced
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D005472:Fluorouracil