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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00040989
First received: July 8, 2002
Last updated: July 9, 2013
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Stage IV Renal Cell Cancer
Recurrent Renal Cell Cancer
Drug: BAY 56-3722
Procedure: enzyme inhibitor therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 0
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040989

  Show 26 Study Locations
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Barbara J. Gitlitz, MD Jonsson Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040989     History of Changes
Other Study ID Numbers: UCLA-0201019, CDR0000069432, UTHSC-0125011152, BAYER-100364, NCI-G02-2090
Study First Received: July 8, 2002
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Enzyme Inhibitors
Camptothecin
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014