Phase I/II trials adv. Colon-Ca?

Hello newsreaders!

We treated a 22 year old man with a cancer of the rectosigmoid.
The disease was asymptomatic before the diagnosis in June 1993.

Initial there was an perforation of the sigmoid and a local
carcinomatosis of the peritoneum (T4N1M0). Histologic type:
mucinous adenocarcinoma.

After surgical resection and and a colostomy, we treated the patient
with a standard chemotherapy (5-FU, leucovorin). First we had a good
clinical response. The patient gained weight and kept nearly asymptomatic
up to now. After 7 month the patient developed an elevation of the
CEA level. Now a laparoscopy showed an advanced disseminated carcinomatosis
of the peritoneum parietale et viscerale. There is no evidence for other
metastases. The patient ist still in an excellent performance status (KPS > 90).

What should we do now?

Alfred M. Cohen states in DeVita: Cancer 4 th Ed p 966f:

"Chemotherapy for Patients Not Benefitting From 5-FU Therapy

Most patients who receive 5-FU-based chemotherapy do not benefit from it
and many patients are candidates for subsequent systemic therapy. Patients
who fail to respond to an initial attempt at flouropyrimidine therapy seldom
respond to 5-FU administered on a different dose or shedule or with a different
modulating agent. Regimens of combined 5-FU and leucovorin usually produce
response rates of 10% or less in patients previously treated with 5-FU,
despite a high level of activity for this combination in previously untreated
patients. Variation of the method of administration of 5-FU is unlikely to
produce clinically meaningful benefit once disease progression has occured
on chemotherapy. Outside of a formal research program, the options available
for patients who do not improve with 5-FU-based therapy are limited.
Occasional responses to nitrosoureas have been observed. Moertel and
colleagues noted a 10% response rate in 112 patients with chlorethyl
nitrosurea as second-line therapy (JNCI 1975; 54:69-71). Likewise, two-drug
combinations containing methyl-CCNU have proved to be effective in less
than 10% of patients (Kemeny N, Cancer 1979; 43:78-82).
Patients with a good performance status should be considered for
investigational chemotherapy protocols."

So I’m looking for promising phase I/II trials in Europe or outside
Europe. Please send me immediately any information about such trials
or any good idea  per EMAIL or Fax! We want to decide about the further
procedure in the 15. week.

hopefully

Willi Schroettle

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Tel.: 08458-4532                             PCNET SCHROETTLE;BAYERN

Klinikum Ingolstadt                          Datex-J  084584950
Medizinische Klinik II             Internet: ws…@novalis.stgt.sub.org
Krumenauerstr. 25
85049 Ingolstadt
Tel.: 0841-880-3360
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