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S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00014144
Collaborator
National Cancer Institute (NCI) (NIH)
31
Enrollment
95
Locations
1
Arm
81.9
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of cancer of the urinary tract.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have advanced cancer of the urinary tract.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the 6-month progression-free survival rate of patients with advanced transitional cell carcinoma of the urothelium treated with ZD 1839.

  • Determine the overall survival and response (confirmed complete and partial response) in these patients treated with this regimen.

  • Determine the qualitative and quantitative toxicity of this regimen in these patients.

  • Evaluate the changes in growth factor protein kinase expression before and after treatment and at the time of disease progression in these patients treated with this regimen.

OUTLINE: Patients receive oral ZD 1839 once daily. Treatment continues 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 30-55 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
May 1, 2003
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: ZD 1839

Drug: gefitinib

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival rate [From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years]

Secondary Outcome Measures

  1. Overall survival [From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years]

  2. Confirmed complete and partial response to ZD 1839 [From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years]

  3. Number and grade of adverse events to ZD 1839 [From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years]

Other Outcome Measures

  1. Changes in growth factor protein kinase expression [Pre-treatment, post-treatment, at time of progression]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra) not curable by surgery or radiotherapy

  • Any T, N0-3, M1 or unresectable M0

  • Poorly differentiated TCC, predominant TCC with rare foci of squamous differentiation, or rare foci of adenocarcinoma allowed

  • Measurable disease

  • At least 1 lesion accessible for biopsy

  • Soft tissue disease that has been irradiated within the past 2 months not considered measurable disease

  • Progressive or recurrent disease after only 1 prior systemic chemotherapy regimen for advanced disease

  • No adenocarcinoma, small cell carcinoma, sarcoma, squamous cell carcinoma, or mixed histology

PATIENT CHARACTERISTICS:
Age:
  • Any age
Performance status:
  • Zubrod 0-2
Life expectancy:
  • Not specified
Hematopoietic:

  • Platelet count at least 100,000/mm3

  • Absolute granulocyte count at least 1,200/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)

  • SGOT no greater than 2 times ULN

Renal:
  • Creatinine no greater than 2 times ULN
Other:

  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

  • Not pregnant or nursing

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:
Biologic therapy:
  • No concurrent filgrastim (G-CSF)
Chemotherapy:

  • See Disease Characteristics

  • No prior adjuvant chemotherapy

  • At least 28 days since prior chemotherapy and recovered

Endocrine therapy:
  • Not specified
Radiotherapy:

  • See Disease Characteristics

  • At least 28 days since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics

  • At least 28 days since prior surgery and recovered

Other:

  • No prior systemic therapy between biopsy and study entry

  • At least 28 days since prior intravesical therapy and recovered

  • No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, or St. John's Wort)

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 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
11 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
12 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
13 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
14 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
15 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
16 Chao Family Comprehensive Cancer Center Orange California United States 92868
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 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
20 David Grant Medical Center Travis Air Force Base California United States 94535
21 University of Colorado Cancer Center Denver Colorado United States 80010
22 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
23 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
24 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
25 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
26 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
27 CCOP - Central Illinois Decatur Illinois United States 62526
28 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
29 Loyola University Medical Center Maywood Illinois United States 60153
30 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
31 CCOP - Wichita Wichita Kansas United States 67214-3882
32 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
33 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
34 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
35 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
36 Tulane University School of Medicine New Orleans Louisiana United States 70112
37 Veterans Affairs Medical Center - New Orleans New Orleans Louisiana United States 70112
38 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
39 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
40 Boston Medical Center Boston Massachusetts United States 02118
41 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
42 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
43 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
44 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
45 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
46 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
47 Henry Ford Hospital Detroit Michigan United States 48202
48 CCOP - Grand Rapids Clinical Oncology Program Grand Rapids Michigan United States 49503
49 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
50 CCOP - Duluth Duluth Minnesota United States 55805
51 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
52 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
53 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
54 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
55 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
56 CCOP - Kansas City Kansas City Missouri United States 64131
57 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
58 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
59 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
60 CCOP - Montana Cancer Consortium Billings Montana United States 59101
61 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
62 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
63 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
64 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
65 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
66 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45267-0502
67 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
68 CCOP - Columbus Columbus Ohio United States 43206
69 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
70 CCOP - Dayton Kettering Ohio United States 45429
71 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
72 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
73 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
74 Oregon Cancer Center Portland Oregon United States 97201-3098
75 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
76 CCOP - Columbia River Program Portland Oregon United States 97213
77 CCOP - Greenville Greenville South Carolina United States 29615
78 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
79 Veterans Affairs Medical Center - Dallas Dallas Texas United States 75216
80 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
81 University of Texas Medical Branch Galveston Texas United States 77555-0209
82 Baylor College of Medicine Houston Texas United States 77030
83 Texas Tech University Health Science Center Lubbock Texas United States 79415
84 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
85 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
86 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
87 CCOP - Scott and White Hospital Temple Texas United States 76508
88 Huntsman Cancer Institute Salt Lake City Utah United States 84112
89 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
90 Eastern Virginia Medical School Norfolk Virginia United States 23507
91 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
92 Swedish Cancer Institute Seattle Washington United States 98104
93 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
94 CCOP - Northwest Tacoma Washington United States 98405-0986
95 Madigan Army Medical Center Tacoma Washington United States 98431-5000

Sponsors and Collaborators

  • Southwest Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Daniel P. Petrylak, MD, Herbert Irving Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00014144
Other Study ID Numbers:
  • CDR0000068509
  • S0031
  • U10CA032102
First Posted:
Oct 15, 2003
Last Update Posted:
Oct 8, 2012
Last Verified:
Oct 1, 2012
Keywords provided by Southwest Oncology Group
recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
recurrent urethral cancer
urethral cancer associated with invasive bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
anterior urethral cancer
posterior urethral cancer
Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Gefitinib

Study Results

No Results Posted as of Oct 8, 2012