Chemotherapy in Treating Patients With Advanced Kidney Cancer
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| ClinicalTrials.gov Identifier: NCT00011973 |
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Recruitment Status :
Completed
First Posted : August 8, 2003
Last Update Posted : April 5, 2013
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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 fenretinide in treating patients who have advanced kidney cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Cancer | Drug: fenretinide | Phase 2 |
OBJECTIVES:
- Determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide.
- Determine progression-free and overall survival of this patient population treated with this drug.
- Determine the quantitative and qualitative toxic effects of this drug in these patients.
OUTLINE: Patients receive oral fenretinide twice a day for 7 days. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study within 9-21 months.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase Two Study Of Fenretinide In Renal Cell Cancer |
| Study Start Date : | December 2000 |
| Actual Primary Completion Date : | October 2005 |
| Actual Study Completion Date : | October 2005 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma
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Measurable disease
- At least 20 mm with conventional techniques OR
- At least 10 mm with spiral CT scan
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No nonmeasurable disease only including:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
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No known brain metastases
- History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy:
- More than 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 2 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide
- No other concurrent uncontrolled illness (e.g., ongoing or active infection)
- No concurrent psychiatric illness or social situation that would preclude study
- History of HIV allowed if no active infection or history of retinitis
- No history of retinal disease, night blindness, or difficulty seeing in the dark
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior biologic therapy allowed
Chemotherapy:
- No more than 1 prior chemotherapy regimen
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery:
- See Disease Characteristics
Other:
- Recovered from prior therapy
- No prior systemic retinoid therapy
- No concurrent antioxidants (e.g., ascorbic acid or vitamin E)
- No other concurrent therapy for renal cell carcinoma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011973
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Pennsylvania | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00011973 History of Changes |
| Other Study ID Numbers: |
CDR0000068465 U01CA062487 ( U.S. NIH Grant/Contract ) P30CA022453 ( U.S. NIH Grant/Contract ) WSU-C-2232 NCI-WSU-910 |
| First Posted: | August 8, 2003 Key Record Dates |
| Last Update Posted: | April 5, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
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stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Additional relevant MeSH terms:
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Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |