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

1. Determine the objective response rate (partial and complete response) in patients with locally recurrent or metastatic renal cell cancer treated with ABT-751.

Secondary

1. Determine the time to tumor progression in patients treated with this drug.
2. Determine the survival of patients treated with this drug.
3. 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

• Not specified

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

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

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)		Ph: 310-825-5788

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