ABT-751 in Treating Patients With Locally Recurrent or Metastatic Renal Cell (Kidney) Cancer
This study is no longer recruiting patients.
Sponsored by: |
Jonsson Comprehensive Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop
growing or die.
PURPOSE: Phase II trial to study the effectiveness of ABT-751 in treating patients who have locallyrecurrent or metastaticrenal
cell (kidney) cancer.
Condition
|
Treatment or Intervention |
Phase |
recurrent renal cell cancer stage III renal cell cancer Stage IV Renal Cell Cancer
|
Drug: ABT-751 Procedure: chemotherapy
|
Phase II
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Kidney Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of ABT-751 in Patients With Locally Recurrent or Metastatic Renal Cell Cancer
Further Study Details:
OBJECTIVES: Primary
- Determine the objective response rate (partial and complete response) in patients with locally recurrent or metastatic renal
cell cancer treated with ABT-751.
Secondary
- Determine the time to tumor progression in patients treated with this drug.
- Determine the survival of patients treated with this drug.
- Determine the toxic effects of this drug in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior immunotherapy (yes vs no).
Patients receive oral ABT-751 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
Patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell cancer
- Locally recurrent or metastatic disease
- Prior immunotherapy allowed provided one of the following criteria are met:
- Refractory to immunotherapy
- Progressive disease after immunotherapy
- Prior nephrectomy allowed provided there is evidence of disease progression after surgery
- At least 1 measurable lesion
- No prior irradiation to target lesions
- Not amenable to curative resection
- No known CNS metastasis
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,200/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Bilirubin < 2.5 mg/dL
- Albumin ≥ 3 g/dL
Renal
- Creatinine ≤ 2.0 mg/dL
- Calcium ≤ 10 mg/dL
Cardiovascular
- No history of unstable cardiovascular conditions
- No uncontrolled hypertension
- No angina
- No New York Heart Association class III congestive heart failure within the past 6 months
- No myocardial infarction within the past 6 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- No neurology toxicity greater than grade 1
- No allergy to sulfa medications
- No other clinically significant medical condition that would preclude study participation
- No other prior or concurrent malignancies except:
- Adequately treated carcinoma in situ of the cervix
- Basal cell or squamous cell skin cancer
- Prior malignancy that was confined and completely surgically resected with no evidence of disease within the past 3 years
PRIOR CONCURRENT THERAPY: Biologic therapy
- See Disease Characteristics
- More than 4 weeks since prior immunotherapy and recovered
- No hematopoietic growth factors given concurrently with study drug
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
Radiotherapy
- See Disease Characteristics
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
- More than 6 weeks since prior nephrectomy
- More than 6 months since prior coronary angioplasty or stenting
- No concurrent surgery
Other
- More than 4 weeks since prior antitumor therapy
- No more than 1 prior investigational therapy as a single agent
- No concurrent colchicine
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Location
Information
California Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,
California,
90095-5907,
United States
Study chairs or principal investigators
Robert Alan Figlin, MD, FACP, Principal Investigator, Jonsson Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000355121; UCLA-0308113; ABBOTT-M02-416
Record last reviewed:
May 2004
Record first received:
April 7, 2004
ClinicalTrials.gov Identifier:
NCT00080717Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-25