Advanced pancreatic cancer: a phase I-II trial of cisplatin, high-dose cytarabine, and caffeine.

In a phase I-II study, 28 patients with advanced pancreatic adenocarcinoma were treated with cisplatin, high-dose cytarabine (ARA-C), and caffeine. This clinical trial was based on a nude mouse-human tumor xenograft model, which demonstrated synergism of these agents by inhibiting the growth of human pancreatic tumors. Toxic effects noted in the clinical study included myelosuppression, moderate nausea and vomiting, and mild renal insufficiency. No toxic effects were directly attributable to caffeine. Eighteen of the 28 patients had measurable or assessable disease; seven (39%) had partial responses (95% confidence intervals, 18%-63%). The median response duration was 6.2 months. Median survival for responders was 9.5 months with two patients surviving for more than 18 months. Median survival for all patients was 6.1 months. The combination of cisplatin, ARA-C, and caffeine is an active and tolerable regimen in the treatment of advanced pancreatic cancer. A phase III trial in which this regimen is being compared with standard therapy is in progress.

Phase II study of idarubicin in advanced cervical carcinoma.

Idarubicin, an anthracycline analogue, was studied in a Phase II trial of 18 patients with advanced cervical carcinoma. Fourteen patients had received no prior chemotherapy (11 had received radiotherapy and three were untreated). All patients received at least two courses of idarubicin at a dose of 12.5 mg/m2 i.v. every 3 weeks. No responses were noted. Fifteen patients had uninterrupted progression of disease and three were stable for 4, 5, and 6 months respectively. Myelosuppression was the most common side effect. Idarubicin displayed no antitumor effect in 18 minimally pretreated cervical carcinoma patients.

Selective use of daunorubicin for remission-induction chemotherapy in acute non-lymphoblastic leukemia.

Twenty-eight patients with acute non-lymphoblastic leukemia (ANLL) were started on induction chemotherapy consisting of Cytosine Arbinoside (Ara C) and 6 thioguanine (TG). Daunorubicin (DNR) was used selectively in 20 of 28 patients who failed to respond by day 14 to the Ara C and TG combination. Seven patients, or 25%, achieved complete remission (CR) without requiring DNR during remission induction. The overall response rate was 89% (64% CR and 25% PR). The median duration of survival for the CR group was 578 days. 189 days for the partial remission (PR) group (P = .02). Patients in the age groups of 18--40 years and with acute myelomonocytic leukemia subtype had the best response rate. There was no difference in the survival of the DNR treated group of complete responders as compared to DNR non-treated group. These results suggest that even though the majority of patients do require DNR for the remission induction, a significant number, perhaps as high as 25% of previously untreated patients, will achieve remission without the use of DNR. A significant minority of patients, therefore, be spared the toxicity of DNR early in the course of their disease.