Medical Breast, Head & Neck, and Investigational Drug Development

Introduction
The Division of Oncology/Hematology has managed many kinds of malignant diseases. Breast cancer, malignant lymphomas, head and neck cancers, recurrent lung cancer and primary unknown carcinoma are the major malignancies encountered. In developing new anticancer drugs, we also treat patients with solid cancers which are resistant to standard treatment or for which standard treatment is not available. Our clinical and research activities are mainly focused on the following six fields:
1. Development of newly synthesized anticancer agents through phase I trials.
2. Disease-oriented clinical trials especially for breast cancer, head and neck cancers, malignant lymphomas and hematological malignancies.
3. High dose chemotherapy with autologous bone marrow and/or peripheral blood stem cell support in experimental settings.
4. Treatment with standard chemotherapy as clinical practice.
5. Palliative care for terminal-stage patients.
6. Research in clinical pharmacology of anticancer agents.
Because of this wide range of activities, the number of protocols for developmental therapeutics has been rapidly increasing. In this chapter, the activity of hematology are not dealt with since these are presented in another section.

Routine Activities
We have managed many kinds of malignant solid tumors through the past year, including breast, head & neck, lung, colorectal, pancreatic, uterine, ovarian, and primary unknown cancers, as well as soft tissue sarcomas. Routine standard chemotherapy was administered as clinical practice to patients having malignant diseases with established chemotherapy who did not meet eligibility for phase III clinical trial projects. Experimental therapeutics were conducted in patients without standard treatment or who failed standard chemotherapy.

New Developments
The clinical trials which we employed in 1997 were as follows;

Phase I Trials
NB-506
UCN-01
TOP-53
DX-8951f
SDZ PSC833
MKC454
Interleukin 12

Phase I/II Trial
Nedaplatin + 5FU (for head and neck cancer)
Docetaxel + Doxorubicin (for breast cancer)

Phase II Trials
SMS201-995 (for digestive disorders in terminal patients)
JM-216 (for breast cancer)

Phase III Trials
JCOG (Japan Clinical Oncology Group) breast cancer trials

Clinical Pharmacology
Dosing formula of carboplatin based on adjusted creatinine clearance
Population pharmacokinetics of docetaxel

(Y. Sasaki)

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