Thirty-six patients with measurable or evaluable advanced
soft tissue sarcoma were entered in a phase II trial with
PALA. Among the 27 evaluable patients, 15 were men, the median age was 55 yr (16-69) and the median performance status (Karnofsky) was 80 (50-100). Most patients had
leiomyosarcoma (8),
liposarcoma (3),
neurofibrosarcoma (3), synovial cell
sarcoma (3), or undifferentiated
sarcoma (3).
Indicator lesions consisted essentially of lung
metastases (21) and/or soft tissue lesions (14). All patients had received prior
chemotherapy with 1-5 regimens and 6 had achieved objective response with these previous treatments.
PALA was given as a 60-min i.v. infusion at a daily dose of 2.5 g/m2 for two consecutive days. Courses were repeated every two weeks. A median number of 3 courses (2-17) were administered. Partial remission (greater than 50%) was obtained in one patient with a
liposarcoma who had also responded to prior
combination chemotherapy. This single response to
PALA lasted 6 weeks from initiation of
therapy. Four patients had unchanged disease after 6+ courses of
PALA and 22 had progressive disease. Toxic effects were generally mild to moderate and included cutaneous toxicity (17),
diarrhea (14),
stomatitis (13), ocular manifestations, consisting of
conjunctivitis, corneal ulceration and/or
photophobia (11),
nausea and
vomiting (6) and, possibly,
seizures (2). There was no evidence of
drug-related myelosuppression. It is concluded that
PALA given at the dose schedule selected for this trial has no significant antitumor activity in advanced
soft tissue sarcoma previously treated with
chemotherapy.