BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer

NCT00040989 | Withdrawn Phase 2

• 5 other identifiers: UCLA-0201019CDR0000069432UTHSC-0125011152BAYER-100364NCI-G02-2090
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 26

Brief Summary

RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.

Conditions

Stage IV Renal Cell Cancer; Recurrent Renal Cell Cancer

Interventions

BAY 56-3722 DRUG

enzyme inhibitor therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma (RCC) * Recurrent AND unresectable disease OR * Unresectable disease OR * Metastatic disease * At least 1 bidimensionally measurable lesion by CT scan or MRI * No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants 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/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present) * No chronic hepatitis B or C Renal: * Creatinine no greater than 1.5 mg/dL * Calcium normal Cardiovascular: * No clinically evident congestive heart failure * No serious cardiac arrhythmias * No symptoms of coronary heart disease * No symptoms of ischemia Other: * HIV negative * No active infections requiring systemic antibacterial, antifungal, or antiviral therapy * No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) * No substance abuse * No medical, psychological, or social conditions that would preclude study * No known or suspected allergy to study drug or any other study agents * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior anticancer vaccine therapy * No prior bone marrow transplantation or stem cell rescue * More than 4 weeks since prior thalidomide and bevacizumab * At least 4 weeks since prior interleukin-2 and interferon * No more than 2 prior regimens * No concurrent bone marrow transplantation or stem cell rescue Chemotherapy: * No prior cytotoxic chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy: * See Disease Characteristics * No prior hormonal therapy for RCC * No concurrent hormonal therapy for RCC Radiotherapy: * See Disease Characteristics * More than 4 weeks since prior radiotherapy * No prior radiotherapy to indicator lesion unless progression is documented Surgery: * See Disease Characteristics * More than 3 weeks since prior major surgery Other: * At least 4 weeks since prior investigational anticancer drugs * No other concurrent investigational anticancer drugs

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (26)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Dwight David Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905-5650, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7353, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642-0001, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Oregon Cancer Institute

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29615, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229-3264, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

20-O-(Nalpha-(4-(3-O-methylfucopyranosyloxy)phenylaminothiocarbonyl)histidylvalyl)camptothecin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Barbara J. Gitlitz, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Last Updated: July 10, 2013

Record last verified: 2006-12

Locations

US (26)