[Clinical and therapeutic study (phase II) using VP-16/213 and methyl-CCNU in patients with inoperable, recurring or metastasizing carcinomas of the gastriointestinal tract].
We carried out a phase-II-study in patients with tumors of the gastrointestinal tract, in order to test the effectiveness of the combination of VP-16/213 and ME-CCNU. We studied 15 patients (3 carcinomas of the stomach, 12 colon carcinomas) in a mostly advanced state of illness (disseminated, n = 13). One patient with gastric cancer attained a partial remission with a duration of remission of 9.1 months and a survival time of 14.1 months; the other two patients with cancer of the stomach were non-responders. 1 of 12 patients with colon carcinoma showed a partial remission (PR) (= 8.3%, or 12.5% in untreated patients n = 8), 7 patients showed no change (NC = 58.3%) and 4 patients had progressive disease (PD). The median duration of remission was 4.9 months, the median survival time 7.9 months. With reference to the success of therapy the median survival time was 10.5 months for patients with partial remission and no remission compared with 4.7 months for patients with progression. Toxicity consisted of nausea and vomiting (n = 11), loss of appetite (n = 10), granulocytopenia (n = 9), thrombocytopenia (n = 8) and hairloss (n = 8). The results achieved are comparable to those of monotherapy with the nitrosoureas.
D000328:Adult; D000368:Aged; D003110:Colonic Neoplasms / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008130:Lomustine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009607:Nitrosourea Compounds / Q000627:therapeutic use*; D011034:Podophyllotoxin / Q000031:analogs & derivatives*; D013274:Stomach Neoplasms / Q000188:drug therapy*; D013727:Terminal Care; D013997:Time Factors
D009607:Nitrosourea Compounds; D005047:Etoposide; D008130:Lomustine; D011034:Podophyllotoxin
Klinisch-therapeutische Studie (Phase II) mit VP-16/213 und Methyl-CCNU bei Patienten mit inoperablen, rezidivierten bzw. metastasierten Karzinomen des Magen- und Darmtraktes.