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Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors Clinical research trials and Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors. Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors  Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more sensitive to the drugs. PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of oblimersen when administered in combination with carboplatin and paclitaxel in patients with advanced solid tumors. - Determine the quantitative and qualitative toxic effects of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of oblimersen. Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12 patients receives treatment as above with oblimersen at the MTD. PROJECTED ACCRUAL: Approximately 31 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 metastatic or unresectable solid tumor for which no standard curative therapy exists - No lymphoma - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of bleeding diathesis Hepatic - Bilirubin normal - AST and ALT no greater than 2.5 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 Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception before, during, and for 3 months after study - No history of allergic reactions to compounds of similar chemical or biological composition to study drugs - No pre-existing grade 2 or greater neuropathy - No ongoing or active infection - No other uncontrolled illness that would preclude study participation - No psychiatric illness or social situation that would preclude study compliance - No HIV-positive patients receiving combination antiretroviral therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during course 1 of study Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No other concurrent chemotherapy for the malignancy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy for the malignancy Surgery - No concurrent surgery for the malignancy Other - No other concurrent investigational agents - No other concurrent anticancer therapies (commercial or investigational)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LynnUmmersen, Study Chair, University of Wisconsin Comprehensive Cancer Center
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting George Wilding 608-263-8610
Additional Information:
Study ID Numbers: CDR0000270902; WCCC-CO-02904,NCI-5912
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054548
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors
2. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
3. Creatine in Treating Patients With Cancer-Associated Weight Loss
4. BMS-184476 in Treating Patients With Advanced Solid Tumors
5. Combination Chemotherapy in Treating Patients With Advanced Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
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