S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery

Adrenocortical Carcinoma Clinical Trial

Official title:

Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00002921
• Other study ID #: CDR0000065324
• Secondary ID: SWOG-9427U10CA03
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: October 3, 2012
• Start date: March 1997
• Est. completion date: January 2004

Study information

• Verified date: October 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may interfere with the growth factor and stop the tumor from growing.

PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer.

Description:

OBJECTIVES: I. Assess the response of patients with adrenocortical carcinoma treated with suramin. II. Evaluate the qualitative and quantitative toxic effects of this therapy.

OUTLINE: Patients are described according to stage, performance status, prior radiotherapy, prior surgery, and prior mitotane therapy. Patients receive suramin IV for 5 days in the first week, then twice a week for 2 weeks, and then weekly for a total of 12 weeks. Hydrocortisone is taken PO twice daily. Following a 12 week rest, patients receive a second course; those with stable or responding disease continue treatment for a maximum of four courses.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued at a rate of 6-7 per year.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed adrenocortical carcinoma in Stage III or IV and incurable by surgery Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: WBC at least 4,000/mm3 Absolute granulocyte count at least 2,000/mm3 Platelet count at least 150,000/mm3 Prothrombin time and partial thromboplastin time no greater than upper limit of normal (ULN) Hepatic: SGOT and alkaline phosphatase no greater than 2 times ULN Renal: Creatinine clearance at least 50 mL/min Serum creatinine no greater than ULN Other: No second malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma of the skin,in situ carcinoma of the cervix, or other cancer for which patient has been disease free for 5 years Not pregnant or nursing Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy At least 4 weeks since prior biologic therapy (one regimen only) Chemotherapy: No concurrent chemotherapy At least 4 weeks since prior mitotane No other prior chemotherapy allowed Endocrine therapy: At least 6 weeks since prior hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiation therapy (to less than 25% of bone marrow) No concurrent radiation therapy Surgery: Prior surgery allowed in relapsed patients with no other prior treatment

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenocortical Carcinoma
• Carcinoma

Intervention

Drug:
• suramin

• therapeutic hydrocortisone

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Boston Medical Center	Boston	Massachusetts
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Beckman Research Institute, City of Hope	Duarte	California
United States	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	CCOP - Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	CCOP - Greenville	Greenville	South Carolina
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Baylor College of Medicine	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	CCOP - Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	CCOP - Dayton	Kettering	Ohio
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Texas Tech University Health Science Center	Lubbock	Texas
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Loyola University Medical Center	Maywood	Illinois
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	MBCCOP - University of South Alabama	Mobile	Alabama
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	CCOP - Columbia River Program	Portland	Oregon
United States	Oregon Cancer Center at Oregon Health Sciences University	Portland	Oregon
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	University of California Davis Medical Center	Sacramento	California
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Louisiana State University Hospital - Shreveport	Shreveport	Louisiana
United States	Providence Hospital - Southfield	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Central Illinois	Springfield	Illinois
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Arizona Cancer Center	Tucson	Arizona
United States	CCOP - Wichita	Wichita	Kansas
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shroder LE, Glass T, Eisenberger M, et al.: Phase II evaluation of suramin in advanced adrenal carcinoma: Southwest Oncology Group (SWOG) trial 9427. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-2361, 153b, 2001.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to suramin		From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles	No
Secondary	Number and grade of adverse events		From date of registration until progression or date of death from any cause, whichever came first, up to four cycles	Yes