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A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of suramin followed by doxorubicin
in patients with advanced solid tumors. II. Describe the toxic effects of suramin with
sequential doses of doxorubicin in these patients. III. Assess the development of peripheral
neuropathy in patients with this treatment. IV. Assess the preliminary evidence of the
antitumor effect of this regimen in these patients. VI. Explore the relationships between
the pharmacokinetic parameters and potential neurotoxicity of suramin in these patients.

OUTLINE: This is a dose-escalation study of doxorubicin. Patients receive suramin IV daily
over 1-2 hours on days 1-4 followed by doxorubicin IV over 10-15 minutes on day 5. Treatment
repeats every 4 weeks for up to 3 courses in the absence of unacceptable toxicity, disease
progression, or clinical deterioration. Starting from course 4, patients receive alternating
courses of doxorubicin IV on day 1 every 4 weeks (courses 4, 6, 8, etc.) and suramin with
doxorubicin (courses 5, 7, 9 etc.) as described above. Cohorts of 3-6 patients receive
escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose preceding that at which 2 or more of 6 patients experience
dose-limiting toxicity. Stable patients who achieve disease response and are able to receive
a target cumulative dose of doxorubicin may discontinue doxorubicin and receive suramin
alone every 8 weeks. Patients are followed at 3 months.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study within 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologic or cytologic confirmation of malignant solid tumor
including, but not limited to: Breast cancer Prostate cancer Colon cancer Adrenocortical
tumors No CNS metastases No conventional therapy for cure or palliation available

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: aPTT and PT no greater than upper limit of normal (ULN)
Bilirubin no greater than 1.5 times ULN AST no greater than 2 times ULN Albumin at least
3.0 g/dL Renal: Creatinine clearance at least 50 mL/min Sodium and potassium normal
Cardiovascular: Ejection fraction normal if prior doxorubicin therapy No New York Heart
Association class III or IV heart disease No history of significant cardiac arrhythmia No
history of congestive heart failure Neurologic: No seizure disorder No grade 2 or greater
peripheral neuropathy Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No insulin-dependent diabetes mellitus No
uncontrolled infection No chronic debilitating disease

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
or immunotherapy No concurrent immunotherapy No concurrent filgrastim (G-CSF) or
sargramostim (GM-CSF) Chemotherapy: More than 4 weeks since prior chemotherapy (6 weeks
for mitomycin or nitrosoureas) and recovered Prior doxorubicin allowed if total dose less
than 300 mg/m2 No other concurrent chemotherapy No more than 2 prior chemotherapy regimens
for metastatic disease Endocrine therapy: No current steroid use of greater than 1.5 mg
dexamethasone (or equivalent) per day Radiotherapy: At least 4 weeks since prior radiation
therapy No radiation therapy to greater than 25% of bone marrow No concurrent radiotherapy
Surgery: At least 4 weeks since prior major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Alex A. Adjei, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

January 2003

Related Keywords:

  • Adrenocortical Carcinoma
  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV colon cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • recurrent colon cancer
  • stage IV adrenocortical carcinoma
  • recurrent adrenocortical carcinoma
  • stage IV prostate cancer
  • recurrent prostate cancer
  • unspecified adult solid tumor, protocol specific
  • Breast Neoplasms
  • Carcinoma
  • Colorectal Neoplasms
  • Prostatic Neoplasms
  • Adrenocortical Carcinoma
  • Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905