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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00041106 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy with gefitinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Renal Pelvis and Ureter Urothelial Carcinoma Urethral Cancer |
Drug: cisplatin Drug: Iressa Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Cisplatin, Gemcitabine, And ZD 1839 (IRESSA) (IND #61187; NSC 715055) For The Treatment Of Advanced Urothelial Tract Carcinoma |
| Enrollment: | 85 |
| Study Start Date: | July 2002 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cisplatin, Gemcitabine, & Iressa
Addition of experimental agent iressa (ZD1839) to chemotherapy treatment for advanced urothelial tract cancer
|
Drug: cisplatin
70 mg/sq m IV over 1 hour on Day 1 of each cycle
Drug: Iressa
500 mg/day PO ea cycle and daily for up to 5 years if no progression after 6 cycles
Other Name: gefitinib; ZD 1839
Drug: gemcitabine hydrochloride
1000 mg/sq m IV over 30 min on Days 1 & 8 of each cycle
|
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Patients also receive oral gefitinib once daily beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission, partial remission, or maintain stable disease continue oral gefitinib once daily for 5 years or until disease progression or unacceptable toxicity occurs.
Patients are followed at least every 3 months for 1 year and then at least every 6 months until disease progression or relapse.
PROJECTED ACCRUAL: A total of 12-50 patients will be accrued for this study within 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the urothelium (bladder, ureter, renal pelvis or urethra)
At least 1 unidimensionally measurable lesion
Nonmeasurable lesions include:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal therapy except:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 82 Study Locations| Study Chair: | George Philips, MD, MPH | Fletcher Allen Health Care - University Health Center Campus |
More Information
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00041106 History of Changes |
| Other Study ID Numbers: | CDR0000069443, U10CA031946, CALGB-90102 |
| Study First Received: | July 8, 2002 |
| Last Updated: | March 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder recurrent urethral cancer anterior urethral cancer |
posterior 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 |
|
Urinary Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urethral Diseases |
Kidney Diseases Ureteral Diseases Gemcitabine Gefitinib Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |