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

This study has been terminated.
(Permanently Closed Due to Lack of Accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002921
First received: November 1, 1999
Last updated: October 3, 2012
Last verified: October 2012

November 1, 1999
October 3, 2012
March 1997
January 2004   (final data collection date for primary outcome measure)
Response to suramin [ Time Frame: From date of registration to progression or date of death from any cause, whichever came first, assessed up to four cycles ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002921 on ClinicalTrials.gov Archive Site
Number and grade of adverse events [ Time Frame: From date of registration until progression or date of death from any cause, whichever came first, up to four cycles ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery
Evaluation of Suramin in Advanced Adrenal Cortical Carcinoma, Phase II

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Adrenocortical Carcinoma
  • Drug: suramin
  • Drug: therapeutic hydrocortisone
Experimental: Suramin
Interventions:
  • Drug: suramin
  • Drug: therapeutic hydrocortisone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
January 2004
January 2004   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002921
CDR0000065324, SWOG-9427, U10CA032102
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Louis E. Schroder, MD Barrett Cancer Center
Southwest Oncology Group
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP