Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer.

This phase II study was conducted to determine the efficacy and toxicity of a gemcitabine (GEM) and oxaliplatin (OX) chemotherapy protocol in patients with unresectable biliary tract cancer (BTC). Patients were treated with GEM 1000 mg m-2 (30 min infusion) on days 1, 8, 15, and OX 100 mg m-2 (2 h infusion) on days 1 and 15 (gemcitabine and oxaliplatin (GEMOX-3 protocol), repeated every 28 days. The data were collected according to the Simon 2-stage design for a single centre phase II study (alpha=0.

[Gemcitabine/cisplatin vs. MVAC. 5 year survival outcome of the phase III study of chemotherapy of advanced urothelial carcinoma in Germany].

Of 405 patients with stage IV transitional cell carcinoma from an international multicenter phase III trial, 70 were randomized in Germany to receive either gemcitabine/cisplatin or standard MVAC systemic chemotherapy for locally advanced or metastatic urothelial cancer. Overall survival as the primary endpoint of the study was similar in both arms (median survival GC 15.4 months vs MVAC 16.

The clonogenic assay with human tumor xenografts: evaluation, predictive value and application for drug screening.

The feasibility, evaluation and predictive value of the colony-forming assay with human tumor xenografts for screening anticancer drugs have been studied. Using human tumors grown in serial passage in nude mice, adequate colony formation was observed in 215 of 251 (86%) different solid human tumors of various histologies. Based on in vitro growth characteristics, a quality-controlled assay protocol was developed.

Preclinical phase II study of ifosfamide in human tumour xenografts in vivo.

The in vivo effects of the oxazaphosphorine compound ifosfamide (IFO) on human tumour xenografts were assessed in thymus aplastic nude mice. The human origin of the tumours was confirmed by isoenzymatic and immunohistochemical methods. Tumour models were selected from a panel of 180 regularly growing, well-characterized xenografts.

Correlation of drug response in patients and in the clonogenic assay with solid human tumour xenografts.

The potential of evaluating the preclinical response of solid tumours was studied in human tumour xenografts in the clonogenic assay. Tumour specimens surgically removed from cancer patients were implanted subcutaneously into thymus-aplastic nude mice. Chemosensitivity of the mouse-grown tumours was tested with a modification of the double-layer soft-agar clonogenic assay.

[Prognostic factors in diffuse malignant mesothelioma of the pleura].

Diffuse malignant pleural mesothelioma (DMM) is associated with a very poor prognosis and is only partially accessible to treatment. On the basis of a retrospective analysis, we made an attempt to identify possible factors that influence the prognosis. Between 1964 and 1986, 84 evaluable patients were treated: the ratio of male to female patients was 4.

Phase-II study with the combination of cisplatin and doxorubicin in advanced malignant mesothelioma of the pleura.

The effectiveness of combination chemotherapy with doxorubicin and cisplatin was studied in patients with advanced malignant pleuramesothelioma. 19 patients were treated intravenously with cisplatin 60 mg/m2/day on days 1 and 2, and with adriamycin 40 mg/m2 on day 3 every 4 weeks. 8/19 patients (46%) responded to chemotherapy; 2 achieved complete remissions (CR), and 6 went into partial remissions (PR).

Colony assay with human tumor xenografts, murine tumors and human bone marrow. Potential for anticancer drug development.

The colony formation of human tumor xenografts from nude mice, of murine tumors, and of human bone marrow (CFU-C) has been investigated in vitro using a modification of the double-layer agar assay described by Hamburger and Salmon. Systematic modification of growth conditions and careful selection of viable tumor tissue enhanced the growth rate (at least 30 colonies per dish) of human tumor xenografts to 86% (98/114). The median plating efficiency was 0.

5-Fluorouracil, 4-epidoxorubicin, and mitomycin C (FEM) combination chemotherapy for advanced gastric carcinoma. A phase-II trial by the "chemotherapiegruppe gastrointestinaler tumoren (CGT)".

In a phase-II-trial 40 patients with advanced gastric cancer were treated with 5-fluorouracil, 4-epidoxorubicin, mitomycin C (FEM) combination therapy. Twenty-five out of 30 patients with measurable disease were evaluable for response after 8 weeks of treatment. Seven patients achieved a partial remission (PR), suggesting a response rate of 28%.

Phase III study of 5-FU and carmustine versus 5-FU, carmustine, and doxorubicin in advanced gastric cancer.

Seventy-seven patients with advanced gastric carcinoma were prospectively randomized to receive 5-FU and carmustine (FB) with or without doxorubicin (FAB). Thirty-five patients were evaluable for response. Neither the response rates (partial remission, 11% for FB and 24% for FAB) nor survival times (median, 4.

Development of three human small cell lung cancer models in nude mice.

The transplantation of seven human small cell lung cancers (SCLC) into athymic nude mice resulted in the development of three tumor lines that are suitable for study of biology and for tests of new drugs and combinations. They were characterized and the response to known drugs was determined. An identical tumor response was observed in the nude mouse system and in the patient in all four comparisons available.

[Phase II study of the water-soluble nitrosourea compound ACNU in advanced colorectal carcinomas].

In a phase-II study 46 patients with advanced colorectal cancer were treated with the new nitrosourea ACNU [1-(2-chloroethyl)-1-nitroso-3 (4-amino-2-methyl-5-pyrimidinyl)methyl-3-nitrosourea]. From 43 evaluable patients, 86% presented distant metastases and 14% an unresectable primary tumour or a recurrent tumour. 24 patients presented a colon and 19 a rectal cancer.

[Prospective randomized study in advanced stomach cancer. Comparison between combinations of 5-fluorouracil and carmustine without and with adriamycin].

In a multi-center study of 77 patients with gastric carcinoma and metastases, the effects of combined 5-fluorouracil and carmustine with or without adriamycin (FB vs FAB) were compared. There was no significant difference between the two treatment groups as to rate of response or survival time, response to treatment was 20% (FB) and 24% (FAB), including "no change" 52% and 56%, respectively. But median survival time among the responders (partial remission and clinical improvement) and of the patients with unchanged findings was significantly longer (8.

Comparison of tumor response in nude mice and in the patients.

In 34 tumors of different origin 50 comparisons between the tumor response in the patients and in nude mice were performed. Combination chemotherapy was more successful than single agent chemotherapy. Out of the 25 combinations given, 9 (36%) effected a remission in comparison to 4 out of 25 (16%) after single agent chemotherapy.

Clonal growth of human tumor xenografts. First experiences in drug testing.

Human tumors growing as nude mice xenografts were investigated for growth in a clonogenic assay. Colony formation of more than 30 colonies per plate was obtained in 47 of 63 tumors examined (74.6%).

[Phase II study of AMSA in adults with acute therapy-refractory leukemias].

The acridine derivative AMSA, Amsacrine, is a new anticancer drug which was effective in patients with advanced AML and ALL in studies performed in USA. In a multicenter phase II trial we treated 27 patients with acute resistant leukemia with AMSA. All presented progressive disease following several drug combination regimens.