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Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors 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 Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors Clinical research trials and Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors 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 Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors 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 Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors 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 > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors  Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Albert Einstein Cancer Research Center
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 combination chemotherapy in treating patients who have metastatic or unresectable solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose, recommended phase II dose, and associated toxicities of the triple combination of continuous infusion fluorouracil, weekly gemcitabine, and oxaliplatin in patients with metastatic or unresectable solid tumors. II. Define sequence dependent toxicities, if any, and establish pharmacokinetic and pharmacodynamic relationships in context of this triple combination chemotherapy in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of oxaliplatin and gemcitabine. For course 1, and then course 3 and beyond, patients receive oxaliplatin IV over 2 hours on day 1, followed by gemcitabine IV over 30 minutes on days 1 and 8, and then fluorouracil IV continuously on days 1-14. For course 2, patients receive treatment in the same manner as in course 1, except gemcitabine is given initially, followed by oxaliplatin, and then fluorouracil. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine 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 toxicity. The recommended phase II dose (RPTD) is defined as the dose preceding MTD. Once RPTD is defined, the cohort is expanded to an additional 12 patients. These patients receive a fixed dose of oxaliplatin, gemcitabine, and fluorouracil as determined by the phase I dose escalation portion of this study. Patients are followed for disease progression. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for the phase I dose escalation portion of this study. An additional 12 patients will be accrued for the recommended phase II dose portion of this study. Accrual will be completed within 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or clinically confirmed metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer effective - No known brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and platinum) and recovered; No more than 1 prior chemotherapy regimen for cancer - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified - Other: No concurrent antiretroviral agents (HAART); No other concurrent investigational agents or commercial therapies --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; Proven Gilbert's syndrome (UGT1A1 promoter mutation or clinical documentation of stress bilirubin levels) allowed; AST/ALT no greater than 3 times upper limit of normal - Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min - Cardiovascular: No symptomatic congestive heart failure; No unstable angina pectoris; No cardiac arrhythmia - Pulmonary: No unexplained respiratory problems (e.g., nonproductive cough, dyspnea, rales, pulmonary infiltrates, hypoxia, or tachypnea) - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No clinical evidence of neuropathy; No prior allergy to platinum compounds; No prior allergy to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy; No other concurrent uncontrolled illness (e.g., active infection)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Albert Einstein Cancer Research Center
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000067487; AECM-1199904138,NCI-T99-0023
Study Start Date: November 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004242
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Improving Pain Management in Patients With Nonhematologic Cancer
2. LY317615 Plus Capecitabine in Treating Patients With Advanced Solid Tumors
3. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. UCN-01 and Carboplatin 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 New York Clinical Trials
Other Bronx Clinical Trials
Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
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