Abstract
The study was a Phase II randomized study to evaluate the efficacy of new agents for the treatment of advanced gastric carcinoma. Patients were randomized to receive single agent chemotherapy with mitoxantrone, etoposide, aclacinomycin-A or spirogermanium. The patients were stratified by prior use of chemotherapy, prior doxorubicin use and ECOG performance status. Patients with a history of cardiac disease or prior doxorubicin exceeding a dose of 400 mg/m2 were restrictively randomized to sopirogermanium or etoposide only. One hundred and fourteen patients were registered for the study. Among 98 evaluable patients there were only two partial responses (both in the etoposide arm), and one complete response in the mitoxantrone arm. The median survival on the study was 3.3 months. One hundred and six patients were analyzable for toxicity. There were four treatment-related deaths and four life-threatening toxicities. Because of low response rates and relatively high toxicities the studied compounds were not deemed worth further investigation for advanced gastric cancer.
Publication types
-
Clinical Trial
-
Clinical Trial, Phase II
-
Multicenter Study
-
Randomized Controlled Trial
-
Research Support, U.S. Gov't, Non-P.H.S.
-
Research Support, U.S. Gov't, P.H.S.
MeSH terms
-
Aclarubicin / adverse effects
-
Aclarubicin / therapeutic use*
-
Adenocarcinoma / drug therapy*
-
Adenocarcinoma / mortality
-
Adenocarcinoma / pathology
-
Antibiotics, Antineoplastic / adverse effects
-
Antibiotics, Antineoplastic / therapeutic use
-
Antineoplastic Agents / adverse effects
-
Antineoplastic Agents / therapeutic use*
-
Antineoplastic Agents, Phytogenic / adverse effects
-
Antineoplastic Agents, Phytogenic / therapeutic use
-
Etoposide / adverse effects
-
Etoposide / therapeutic use*
-
Female
-
Humans
-
Male
-
Mitoxantrone / adverse effects
-
Mitoxantrone / therapeutic use*
-
Organometallic Compounds / adverse effects
-
Organometallic Compounds / therapeutic use*
-
Spiro Compounds / adverse effects
-
Spiro Compounds / therapeutic use*
-
Stomach Neoplasms / drug therapy*
-
Stomach Neoplasms / mortality
-
Stomach Neoplasms / pathology
Substances
-
Antibiotics, Antineoplastic
-
Antineoplastic Agents
-
Antineoplastic Agents, Phytogenic
-
Organometallic Compounds
-
Spiro Compounds
-
spirogermanium
-
Etoposide
-
Aclarubicin
-
Mitoxantrone