- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003038
Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Breast Diseases
- Prostatic Diseases
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Breast Neoplasms
- Prostatic Neoplasms
- Carcinoma
- Adrenocortical Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Antiprotozoal Agents
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Trypanocidal Agents
- Doxorubicin
- Liposomal doxorubicin
- Suramin
Other Study ID Numbers
- CDR0000065661
- P30CA015083 (U.S. NIH Grant/Contract)
- U01CA069912 (U.S. NIH Grant/Contract)
- 960105 (OTHER: Mayo Clinic Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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