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

Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00040989
Enrollment
0
Registered
2003-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2013-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer

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.

Detailed description

OBJECTIVES: * Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722. * Determine the duration of response, time to progression, and survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

Interventions

DRUGBAY 56-3722

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Jonsson Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026