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Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors

Primary Purpose

Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
doxorubicin hydrochloride
suramin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adrenocortical Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 2, 2011
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003038
Brief Title
Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
Official Title
A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with suramin plus doxorubicin in treating patients with advanced solid tumors.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
suramin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex A. Adjei, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors

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