|
PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors Clinical research trials and PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors. PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors clinical trial. Participants frequently get the best healthcare available for their PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors  PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining PS-341 and chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of PS-341 and paclitaxel administered in combination with carboplatin in patients with advanced solid tumors. - Compare the tolerability and efficacy of the different sequences of this regimen in these patients. - Determine the clinical toxic effects and pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the therapeutic activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of PS-341 and paclitaxel. Patients are assigned to 1 of 2 treatment groups. - Group A: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and PS-341 IV over 3-5 seconds on days 2, 5, and 8. - Group B: Patients receive PS-341 IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Treatment in both groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After 6 courses of paclitaxel and carboplatin, patients with stable or responding disease may continue with PS-341 alone at the discretion of the investigator. Cohorts of 3-6 patients in each group receive escalating doses of PS-341 and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 24-96 patients will be accrued for this study within 25 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists - No hematologic malignancies - No symptomatic CNS metastases - Brain metastases allowed if previously treated (radiotherapy and/or surgery) and patient is stable for at least 8 weeks PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - HIV negative - No peripheral neuropathy grade 2 or greater - No uncontrolled infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy - No prior bone marrow transplantation - No concurrent immunotherapy Chemotherapy: - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 30% of bone marrow - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - No concurrent investigational ancillary therapy - No concurrent enrollment in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy) for symptom control or therapeutic intents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexAdjei, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000069108; MAYO-MC0012,NCI-1860
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028587
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
2. DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
3. Irinotecan and Gemcitabine in Treating Patients With Refractory Advanced Solid Tumors
4. Paclitaxel in Treating Older Patients With Solid Tumors
5. SU6668 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
|
|
|
|
|
|
|
|
