Phase II Study of ABT-751 in Patients With Locally Recurrent or Metastatic Renal Cell Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
ABT-751 in Treating Patients With Locally Recurrent or Metastatic Renal Cell (Kidney) Cancer
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase II
|
|
|
|
Treatment
|
|
|
|
Closed
|
|
|
|
18 and over
|
|
|
|
NCI, Pharmaceutical / Industry
|
|
|
|
UCLA-0308113 ABBOTT-M02-416, NCT00080717
|
|
|
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.
Entry Criteria 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
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
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Absolute neutrophil count ≥ 1,200/mm3
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm3
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
Expected Enrollment A total of 60 patients (30 per stratum) will be accrued for this study. 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.
Trial Contact Information
Trial Lead Organizations Jonsson Comprehensive Cancer Center at UCLA | | | Robert Figlin, MD, FACP, Principal investigator(Contact information may not be current) | | | |
Registry Information | | Official Title | | A Phase II Study Evaluating the Efficacy and Safety of ABT-751 in Patients with Renal Cell Carcinoma | | Trial Start Date | | 2003-11-21 | | Registered in ClinicalTrials.gov | | NCT00080717 | | Date Submitted to PDQ | | 2004-01-29 | | Information Last Verified | | 2004-05-18 | | NCI Grant/Contract Number | | P30-CA16042 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |