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

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ClinicalTrials.gov Identifier: NCT00003038

Recruitment Status : Completed

First Posted : April 30, 2004

Last Update Posted : August 3, 2011

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Mayo Clinic

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.

Condition or disease	Intervention/treatment	Phase
Adrenocortical Carcinoma Breast Cancer Colorectal Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific	Drug: doxorubicin hydrochloride Drug: suramin	Phase 1

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 Design


Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors
Study Start Date :	October 1997
Actual Primary Completion Date :	January 2003
Actual Study Completion Date :	January 2003

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer Prostate cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

Genetic and Rare Diseases Information Center resources: Adrenocortical Carcinoma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003038

Locations


United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators


Study Chair:	Alex A. Adjei, MD, PhD	Mayo Clinic

More Information


Responsible Party:	Alex A. Adjei, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier:	NCT00003038 History of Changes
Other Study ID Numbers:	CDR0000065661 U01CA069912 ( U.S. NIH Grant/Contract ) P30CA015083 ( U.S. NIH Grant/Contract ) 960105 ( Other Identifier: Mayo Clinic Cancer Center )
First Posted:	April 30, 2004 Key Record Dates
Last Update Posted:	August 3, 2011
Last Verified:	August 2011

Keywords provided by Mayo Clinic:


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

Additional relevant MeSH terms:


Adrenocortical Carcinoma Carcinoma Breast Neoplasms Prostatic Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases	Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Adenocarcinoma Adrenal Cortex Neoplasms Adrenal Gland Neoplasms Endocrine Gland Neoplasms Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases

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