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AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer Clinical research trials and AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer. AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer clinical trial. Subjects typically recieve the finest healthcare available for their AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer  AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
For Condition: stage 4 renal cell cancer,recurrent renal cell cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: AG-013736 may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of AG-013736 as second-line therapy in treating patients who have metastaticrenal cell (kidney) cancer.
Details: OBJECTIVES: Primary - Determine the activity of AG-013736 as second-line treatment, in terms of overall objective response rate, complete response, and partial response, in patients with metastatic renal cell cancer. Secondary - Determine the safety profile of this drug in these patients. - Determine the time to progression in patients treated with this drug. - Determine the duration of response in patients treated with this drug. - Determine the overall survival of patients treated with this drug. - Determine the effects of this drug on health-related quality of life in these patients. - Correlate the pharmacokinetics of this drug with response or adverse events in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral AG-013736 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline; at days 29 and 57 during therapy; every 8 weeks during therapy; at days 30 and 45 post-therapy; and then every 3 months for at least 1 year after the first dose of study drug. Patients are followed at days 30 and 45 and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 30-52 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed renal cell cancer - Metastatic disease - Unresected primary tumors allowed provided there is evidence of metastatic disease - Failed 1 prior cytokine-based therapy (interleukin-2 and/or interferon alfa) due to disease progression or unacceptable treatment-related toxicity - At least one unidimensionally measurable target lesion at least 2 cm (1 cm allowed for spiral CT scan) - Not in a previously irradiated field* - No evidence of brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST and ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Bilirubin no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min - Urinary protein less than 2+ by urine dipstick OR - Urinary protein less than 2 g/24-hour urine collection Cardiovascular - No evidence of preexisting uncontrolled hypertension - Baseline systolic blood pressure no greater than 140 mm Hg and baseline diastolic blood pressure no greater than 90 mm Hg Gastrointestinal - Able to take oral medication - No requirement for IV alimentation - No active gastrointestinal bleeding unrelated to cancer (e.g., hematemesis, hematochezia, or melena) within the past 3 months unless there is resolution documented by endoscopy or colonoscopy - No malabsorption syndromes Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation - No active seizure disorder - No other serious uncontrolled medical disorders - No active infection - No dementia or significantly altered mental status that would preclude giving informed consent or complying with study - No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the breast or cervix. PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior antiangiogenesis agents, including thalidomide Chemotherapy - No concurrent chemotherapy for the primary disease Endocrine therapy - No concurrent hormonal therapy for the primary disease - No concurrent dexamethasone Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy Surgery - More than 4 weeks since prior major surgery - No prior surgical procedures affecting absorption (including gastric resection) Other - No other prior systemic treatment for renal cell cancer - More than 6 months since prior treatment for active peptic ulcer disease - No other concurrent experimental medications for the primary disease - No other concurrent anticancer therapy - No concurrent chronic antacid therapy with histamine H - antagonists or proton pump inhibitors - Concurrent locally acting antacids (e.g., Mylanta®, Maalox®, or Amphojel®) for acute control of gastric acid allowed provided the antacids are not administered 2 hours before, during, and 2 hours after study drug administration - No concurrent drugs that are known potent CYP3A4 inhibitors, including any of the following: - Grapefruit juice - Verapamil - Ketoconazole - Miconazole - Itraconazole - Erythromycin - Clarithromycin - Indinavir - Saquinavir - Ritonavir - Nelfinavir - Lopinavir - Delavirdine - No concurrent drugs that are known CYP3A4 or CYP1A2 inducers, including any of the following: - Carbamazepine - Felbamate - Omeprazole - Phenobarbital - Phenytoin - Primidone - Rifabutin - Rifampin - Hypericum perforatum (St. John's wort)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMotzer, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Beverly Drucker 646-422-4466
Additional Information:
Study ID Numbers: CDR0000350081; PFIZER-A4061012,MSKCC-03117
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077272
Other Recurrent Renal Cell Cancer Studies:
1. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
2. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
3. Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
4. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors
5. Interferon alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
AG-013736 as Second-Line Therapy in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
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