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Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003038
  Purpose

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 Intervention Phase
Adrenocortical Carcinoma
Breast Cancer
Colorectal Cancer
Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: doxorubicin hydrochloride
Drug: suramin
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial of Suramin With Sequential Doxorubicin in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003038

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Alex A. Adjei, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065661, MAYO-960105, NCI-T97-0020
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003038     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Anti-Infective Agents
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Colonic Diseases
Adrenal Gland Diseases
Urogenital Neoplasms
Rectal Diseases
Anti-Bacterial Agents
Adrenal Cortex Neoplasms
Breast Diseases
Endocrine Gland Neoplasms
Digestive System Neoplasms
Skin Diseases
Adrenocortical Carcinoma
Suramin
Endocrine System Diseases
Breast Neoplasms
Anthelmintics
Intestinal Diseases
Genital Diseases, Male
Doxorubicin
Intestinal Neoplasms
Recurrence
Carcinoma
Digestive System Diseases
Adrenal Gland Neoplasms
Gastrointestinal Neoplasms
Endocrinopathy
Adrenal Cortex Diseases

Additional relevant MeSH terms:
Trypanocidal Agents
Anti-Infective Agents
Antiprotozoal Agents
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Adrenal Gland Diseases
Urogenital Neoplasms
Antibiotics, Antineoplastic
Rectal Diseases
Antiparasitic Agents
Neoplasms by Site
Therapeutic Uses
Adrenal Cortex Neoplasms
Breast Diseases
Antinematodal Agents
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Skin Diseases
Adrenocortical Carcinoma
Suramin
Endocrine System Diseases
Breast Neoplasms
Anthelmintics
Intestinal Diseases
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009