# TRIAL OF ICRF-187 TO DECREASE DOXORUBICIN CARDIOMYOPATHY

> **NIH NIH R01** · NEW YORK UNIVERSITY · 1987 · $25,200

## 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
preventing this cardiomyopathy in 132 patients with advanced inoperable
breast cancer who will be receiving a doxorubicin based combination of
cytoxic 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 administration of doxorubicin.

Patients will be monitored for acute toxicity to the hemotherapeutic 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 nuclear gated pool
scans and pathologic changes seen in right ventricular endomyocardial
biopsies.  Biopsies will be done in 36 patients.

## Key facts

- **NIH application ID:** 3174153
- **Project number:** 3R01CA036524-03S1
- **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:** 1987
- **Award amount:** $25,200
- **Award type:** 3
- **Project period:** 1984-08-01 → 1988-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3174153

## Citation

> US National Institutes of Health, RePORTER application 3174153, TRIAL OF ICRF-187 TO DECREASE DOXORUBICIN CARDIOMYOPATHY (3R01CA036524-03S1). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3174153. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*