Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00016939

Collaborator

National Cancer Institute (NCI) (NIH)

101

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Drug: alvocidib	Phase 2

Detailed Description

OBJECTIVES:

Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol.
Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug.
Determine the qualitative and quantitative toxic effects of this drug in this patient population.
Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer

Study Start Date :

May 1, 2001

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer
At least 1 unidimensionally measurable lesion
At least 20 mm by conventional techniques OR
At least 10 mm by spiral CT scan
Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable
Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field
No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

No hypercoagulable state other than renal cell cancer

Hepatic:

Not specified

Renal:

Not specified

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No prior isolated occurrence of deep venous thrombosis within the past 6 months

Pulmonary:

No prior isolated occurrence of pulmonary embolism within the past 6 months

Other:

No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I)
No other uncontrolled illness (e.g., diabetes mellitus)
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed
At least 28 days since prior immunotherapy and recovered
No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

No prior chemotherapy for renal cell cancer

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
At least 21 days since prior radiotherapy and recovered

Surgery:

See Disease Characteristics
Prior resection of primary tumor allowed
At least 28 days since prior surgery and recovered

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
3	CCOP - Greater Phoenix	Phoenix	Arizona	United States	85006-2726
4	Veterans Affairs Medical Center - Phoenix (Hayden)	Phoenix	Arizona	United States	85012
5	Veterans Affairs Medical Center - Tucson	Tucson	Arizona	United States	85723
6	Arizona Cancer Center	Tucson	Arizona	United States	85724
7	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
8	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas	United States	72205
9	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California	United States	91010-3000
10	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
11	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California	United States	90073
12	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
13	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
14	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
15	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
16	University of California Davis Cancer Center	Sacramento	California	United States	95817
17	University of California Davis Medical Center	Sacramento	California	United States	95817
18	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
19	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
20	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
21	David Grant Medical Center	Travis Air Force Base	California	United States	94535
22	University of Colorado Cancer Center	Denver	Colorado	United States	80010
23	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
24	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342-1701
25	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia	United States	30905-5650
26	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
27	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
28	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
29	CCOP - Central Illinois	Decatur	Illinois	United States	62526
30	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois	United States	60141
31	Loyola University Medical Center	Maywood	Illinois	United States	60153
32	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
33	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
34	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
35	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky	United States	40511-1093
36	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
37	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
38	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
39	Veterans Affairs Medical Center - New Orleans	New Orleans	Louisiana	United States	70112
40	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
41	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71130
42	Boston Medical Center	Boston	Massachusetts	United States	02118
43	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts	United States	02130
44	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
45	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
46	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0752
47	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
48	Veterans Affairs Medical Center - Detroit	Detroit	Michigan	United States	48201-1932
49	Henry Ford Hospital	Detroit	Michigan	United States	48202
50	CCOP - Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan	United States	49503
51	Providence Hospital - Southfield	Southfield	Michigan	United States	48075-9975
52	CCOP - Duluth	Duluth	Minnesota	United States	55805
53	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi	United States	39531-2410
54	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
55	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi	United States	39216
56	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi	United States	39534-2576
57	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
58	CCOP - Kansas City	Kansas City	Missouri	United States	64131
59	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110-0250
60	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
61	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
62	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
63	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5138
64	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
65	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
66	Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
67	University of Rochester Medical Center	Rochester	New York	United States	14642
68	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
69	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio	United States	45220-2288
70	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45267-0502
71	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
72	CCOP - Columbus	Columbus	Ohio	United States	43206
73	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
74	CCOP - Dayton	Kettering	Ohio	United States	45429
75	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
76	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
77	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma	United States	73104
78	Oregon Cancer Center	Portland	Oregon	United States	97201-3098
79	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
80	CCOP - Columbia River Program	Portland	Oregon	United States	97213
81	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina	United States	29401-5799
82	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
83	CCOP - Greenville	Greenville	South Carolina	United States	29615
84	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
85	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
86	University of Texas Medical Branch	Galveston	Texas	United States	77555-0209
87	Baylor College of Medicine	Houston	Texas	United States	77030
88	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
89	Texas Tech University Health Science Center	Lubbock	Texas	United States	79415
90	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811
91	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78284
92	Veterans Affairs Medical Center - Temple	Temple	Texas	United States	76504
93	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
94	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
95	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah	United States	84148
96	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507
97	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
98	Swedish Cancer Institute	Seattle	Washington	United States	98104
99	Veterans Affairs Medical Center - Seattle	Seattle	Washington	United States	98108
100	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
101	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5000