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

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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

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.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Adrenocortical Carcinoma

Intervention

doxorubicin hydrochloride


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

October 1997

Completion Date

January 2003

Primary Completion Date

January 2003

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alex A. Adjei, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00003038

Organization ID

CDR0000065661

Secondary IDs

U01CA069912


Study Sponsor

Mayo Clinic

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

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


Verification Date

August 2011