Journal of Clinical Oncology, Vol 15, 2414-2419, Copyright © 1997 by American Society of Clinical Oncology
Phase II trial of paclitaxel and granulocyte colony-stimulating factor in patients with pancreatic carcinoma: a Southwest Oncology Group study
RP Whitehead, J Jacobson, TD Brown, SA Taylor, GR Weiss and JS Macdonald
Texas Tech University Health Science Center, Lubbock, USA.
PURPOSE: Pancreatic cancer is difficult to treat, with most patients
surgically unresectable at the time of diagnosis. Radiotherapy and
chemotherapy can offer palliation, but more effective therapy is needed.
This trial evaluated the effects of an aggressive schedule of paclitaxel
given with granulocyte colony-stimulating factor (G-CSF) to patients with
advanced pancreatic cancer. PATIENTS AND METHODS: All patients were
required to have a histologic diagnosis of pancreatic adenocarcinoma with
measurable disease and no prior chemotherapy or radiation therapy. Patients
had to have performance status of 0 to 2, pretreatment absolute granulocyte
count > or = 1,500/microL, and platelet count greater than or equal to
the institutional lower limit of normal. Following pretreatment with
dexamethasone, diphenhydramine, and cimetidine, patients received
paclitaxel at a dose of 250 mg/m2 by 24-hour infusion on day 1, repeated
every 21 days. G-CSF was given at a dose of 5 microg/kg/d on days 3 to 18
or until two consecutive absolute neutrophil counts (ANCs) > or =
10,000/microL were obtained. Doses of paclitaxel were modified depending on
nadir counts. RESULTS: Forty-five patients were entered onto this study,
with six ineligible. For the 39 eligible patients, there was one complete
response (CR) and two partial responses (PRs), five stable/no responses, 23
increasing disease, two early deaths, and six patients whose assessment was
inadequate to determine response. The response rate was therefore three of
39 or 8% (95% confidence interval [CI], 2% to 21%). The median survival
time for the 39 eligible patients was 5 months. The most common toxicities
were anemia, leukopenia/granulocytopenia, malaise/fatigue, nausea/vomiting,
alopecia, thrombocytopenia, paresthesias, and liver function abnormalities.
There was one death due to sepsis. CONCLUSION: Single- agent paclitaxel in
this dose and schedule has minimal activity in pancreatic adenocarcinoma
patients.
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