# TRIAL OF ICRF-187 TO DECREASE DOXORUBICIN CARDIOMYOPATHY

> **NIH NIH R01** · NEW YORK UNIVERSITY · 1988 · $130,808

## Abstract

Doxorubicin induced cardiomyopathy limits the cumulative dose
of this drug which can be administered to cancer patients.  We
propose a randomized clinical trial to test the effectiveness of
the agent ICRF-187 in preventig this cardiomyopathy in 132
patients with advanced inoperable breat cancer who will be
receiving a doxorubicin based combination of cytotoxic drugs.
ICRF-187 was chosen because in extensive animal studies it
consistently prevented the pathologic changes of chronic
doxorubicin cardiomyopathy.  The drug has also been tested in
humans in clinical trials and has been shown to be non-toxic in the
doses proposed for this study.  All patients will receive 5-
fluorouracil, doxorubicin, and cyclophosphamide and will be
randomized to receive ICRF-187.  The ICRF will be given as an
I.V. bolus 30 minutes prior to the administrations of doxorubicin.

Patients will be monitored for acute toxicity to the
chemotherapeutic agents by clinical examination, blood
examinations and x-rays.

The primary endpoint of the study is the development of
cardiotoxicity which will be assessed by clinical examination, falls
in left ventricular ejection fractions as measured by resting and
exercise nucler gated pool scans and pathologic changes seen in
right ventricular endomyocardial biopsies.  Biopsies will be done
in 36 patients.

The study was started and accrued 87 patients preliminary results
indicated statistically significant cardiac protection as measured
by nuclear gated pool scans.  Clinical and biopsy data all suggest
cardiac protection but are not statistically significant at this
time.  Non cardiac toxicity and antitumor efficacy of the drug
combination are not elected by the addition of ICRF-187 in this
dose and schedule.

This proposal is to complete the original accrual of injection and
complete data analysis.

## Key facts

- **NIH application ID:** 3174152
- **Project number:** 2R01CA036524-04
- **Recipient organization:** NEW YORK UNIVERSITY
- **SAM.gov UEI:** NX9PXMKW5KW8
- **Principal Investigator:** JAMES SPEYER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1988
- **Award amount:** $130,808
- **Award type:** 2
- **Project period:** 1984-08-01 → 1990-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3174152

## Citation

> US National Institutes of Health, RePORTER application 3174152, TRIAL OF ICRF-187 TO DECREASE DOXORUBICIN CARDIOMYOPATHY (2R01CA036524-04). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3174152. Licensed CC0.

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