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Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor Clinical research trials and Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor. Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor clinical trial. Subjects frequently obtain the most expert healthcare possible for their Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor  Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: 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 tumor cells. PURPOSE: Phase I trial to study the effectiveness of docetaxel and oxaliplatin in treating patients who have metastatic or recurrent solid tumor.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel when followed by oxaliplatin in patients with metastatic or recurrent solid tumors. II. Describe the toxicities of this regimen in this patient population at each dose level studied. III. Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of docetaxel. Patients receive docetaxel IV over 1 hour followed by oxaliplatin IV over 2 hours on day 1 every 3 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed for disease progression. PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed metastatic or recurrent solid tumor that has failed standard therapy or for which no standard therapy exists No known brain metastases or carcinomatosis meningitis --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: Prior chemotherapy, including fluorouracil and cisplatin, allowed At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: At least 30 days since other prior investigational drugs No other concurrent investigational or commercial agents or therapies No concurrent antiretroviral therapy (HAART) --Patient Characteristics-- Age: 18 and over Performance status: SWOG 0-2 OR Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.25 times ULN Calcium no greater than 12 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No evidence of neuropathy No history of allergy to platinum compounds No history of allergy to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No uncontrolled concurrent illness (e.g., ongoing or active infection) No medical, social, or psychological factors that would preclude consent and follow up
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Heinz-JosefLenz, Study Chair, Beckman Research Institute
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Additional Information:
Study ID Numbers: CDR0000067488; CHNMC-PHASEI-24,NCI-T99-0004,CHNMC-IRB-99081,LAC-USC-OC-99-2
Study Start Date: March 2000
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004243
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
2. Benzoylphenylurea in Treating Patients With Advanced Cancer
3. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
4. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
5. E7070 in Treating Patients With Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor
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