SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00006002 | Completed Phase 2

• 4 other identifiers: 10428UCCRC-10428UCCRC-NCI-49NCI-49
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 18

Brief Summary

RATIONALE: SU5416 may stop the growth of prostate cancer by stopping blood flow to the tumor. Dexamethasone may be effective in slowing the growth of prostate cancer cells. It is not yet known whether SU5416 or dexamethasone is more effective in treating progressive prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of SU5416 with that of dexamethasone in treating patients who have progressive prostate cancer that has not responded to hormone therapy.

Conditions

Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  3 years

Study Arms (2)

Arm B

EXPERIMENTAL

dexamethasone followed by SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment if tumor grows.

Drug: dexamethasone; Drug: semaxanib

Arm A

EXPERIMENTAL

SU5416 done twice weekly (Monday and Thursday or Tuesday and Friday) every week for 4 weeks (a total of 8 doses). Four weeks of treatment (8 doses) is considered 1 cycle of treatment

Drug: semaxanib

Interventions

dexamethasone DRUG

Arm B

semaxanib DRUG

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer not amenable to curative treatment with surgery or radiotherapy * Progressive disease defined by 1 of the following criteria: * New bone scan lesions * New or progressive radiologic lesions * Sequential increases in PSA on at least 2 successive measurements no less than 2 weeks apart of at least 50% above nadir on prior therapy provided absolute value at time of enrollment is at least 5 ng/mL * Progressive disease, as defined above, despite adequate hormonal therapy defined by all of the following: * Continued treatment with an LHRH agonist or prior orchiectomy * Sequential or concurrent treatment with an antiandrogen (e.g., flutamide, nilutamide, or bicalutamide) * Trial of antiandrogen withdrawal at least 4 weeks prior to study * CNS metastasis allowed if: * Previously treated * Neurologically stable * Oral or intravenous steroids or anticonvulsants not required * Brain scan (CT or MRI) within the past 2 weeks shows no active or residual disease * Negative brain scan required if neurologic signs or symptoms suggestive of CNS metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No uncompensated coronary artery disease * No history of myocardial infarction or severe unstable angina within the past 6 months * No severe peripheral vascular disease associated with diabetes mellitus * No deep venous or arterial thrombosis within the past 3 months Pulmonary: * No pulmonary embolism within the past 3 months Other: * Not pregnant * Fertile patients must use effective contraception * No significant uncontrolled underlying medical or psychiatric illness * No serious active infection * No other prior or concurrent malignancy except nonmelanoma skin cancer unless completed therapy and considered to be at less than 30% risk of relapse * No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy * No other concurrent chemotherapy * No other concurrent investigational antineoplastic drugs Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

LaGrange Memorial Hospital

LaGrange, Illinois, 60525, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Division of Hematology/Oncology

Park Ridge, Illinois, 60068, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46617, United States

Location

Oncology Care Associates, P.L.L.C.

Saint Joseph, Michigan, 49085, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dexamethasone; Semaxinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Walter M. Stadler, MD, FACP

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: August 29, 2003
• Study Start: June 1, 2000
• Primary Completion: September 1, 2002
• Study Completion: January 1, 2006
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (18)