Phase II trial of recombinant DNA gamma-interferon in advanced colorectal cancer: a Southwest Oncology Group study.
Fifty evaluable patients with advanced colorectal cancer, but without prior chemotherapy or immunotherapy, were randomized to one of two schedules of recombinant gamma-interferon (rGIFN). Twenty-four evaluable patients received rGIFN as a 2-h intravenous infusion daily x 5 every other week at a starting dose of 4.0 x 10(6) IU/m2/day (arm I). Twenty-six evaluable patients received rGIFN as a 24-h continuous intravenous infusion daily x 5 every month at a starting dose of 2.6 x 10(6) IU/m2/day (arm II). Toxicities on both schedules included flu-like symptoms, fevers/rigors, nausea/vomiting, hypotension, leukopenia, hepatotoxicity, nephrotoxicity, diarrhea, anemia, confusion, and ileus. Toxicity appeared to be more severe on arm I. No antitumor responses were observed, with 95% confidence intervals of 0 to 14% for arm I and 0 to 13% for arm II.
Brown
T D
TD
Department of Medicine/Oncology, University of Texas Health Science Center, San Antonio.
Goodman
P J
PJ
Fleming
T
T
Macdonald
J S
JS
O'Rourke
T
T
Taylor
S A
SA
Neefe
J R
JR
Gaynor
E
E
D000328:Adult; D000368:Aged; D015179:Colorectal Neoplasms / Q000628:therapy*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007371:Interferon-gamma / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D007371:Interferon-gamma