Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency |
| Study Start Date: | May 2000 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine.
- Determine the toxicity of this regimen in this patient population.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium
- Mixed histologies containing a component of transitional cell carcinoma allowed
- Bidimensionally measurable disease
- No clinical evidence of CNS metastases
- Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR
- Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR
- SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN
Renal:
- Creatinine no greater than 3.0 mg/dL
- Glomerular filtration rate no greater than 50 mL/min
Cardiovascular:
- No history of American Heart Association class III or IV heart disease
- No uncontrolled congestive heart failure
- No severe cardiac arrhythmias
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No preexisting peripheral neuropathy grade 2 or greater
- No active unresolved infection requiring parenteral antibiotics within the past 7 days
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior systemic biologic response modifier therapy for advanced disease
- Prior intravesical BCG for superficial disease allowed
Chemotherapy:
- Prior intravesical chemotherapy for superficial disease allowed
- No prior chemotherapy for advanced disease
- At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV), or cisplatin as a radiosensitizer
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery and recovered
Other:
- No concurrent hemodialysis
Contacts and Locations| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, New Jersey | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07019 | |
| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10461 | |
| James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Wisconsin | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| CCOP - Marshfield Medical Research and Education Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| Study Chair: | David J. Vaughn, MD | Abramson Cancer Center of the University of Pennsylvania |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005644 History of Changes |
| Other Study ID Numbers: | CDR0000067810, E-5899 |
| Study First Received: | May 2, 2000 |
| Last Updated: | September 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III bladder cancer recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder recurrent urethral cancer distal urethral cancer |
proximal urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Renal Insufficiency Urethral Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Kidney Diseases Urethral Diseases Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Ureteral Diseases Gemcitabine Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 21, 2013