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Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors 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 Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors Clinical research trials and Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors 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 Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors. Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors 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 Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors clinical trial. Subjects frequently obtain the most expert healthcare possible for their Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors 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 > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors  Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors
Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer 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 with paclitaxel and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol when administered in combination with paclitaxel and cisplatin in patients with refractory adult solid tumors. II. Investigate the clinical pharmacokinetics of intravenous flavopiridol when administered in combination with paclitaxel in these patients. III. Obtain preliminary data on the therapeutic activity of flavopiridol when administered in combination with paclitaxel in these patients. IV. Evaluate surrogate markers of activity such as inhibition of PKC or CDK1 in these patients. PROTOCOL OUTLINE: This is an open label, dose escalation study. Patients receive paclitaxel IV over 3 hours on day 1. On day 2, patients receive cisplatin IV over 20 minutes followed by a 24 hour infusion of flavopiridol. Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Dose escalation in cohorts of 3-6 patients each continues 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. Patients are followed every 6 weeks. PROJECTED ACCRUAL: Approximately 46-73 patients will be accrued for this study within 6 more months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven solid tumors that are refractory or recurrent - No CNS primary or metastatic disease --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified - Other: No presence of toxic effects from prior therapy --Patient Characteristics-- - Age: 18 and over - Performance Status: Karnofsky at least 60% - Hematopoietic: WBC at least 3,500/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST and ALT no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: At least 6 months since prior cardiac arrhythmias, myocardial infarction, or congestive heart failure - Other: Not pregnant or nursing; Effective contraceptive method must be used for 2 months after study completion; Not HIV positive; No uncontrolled or serious infection; No pre-existing grade 3 or greater neurotoxicity; Must be mentally capable of understanding the explanation of the study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchwartz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000065571; MSKCC-9677A,NCI-T96-0091
Study Start Date: July 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003004
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Vaccine Therapy in Treating Patients With Advanced Cancer
2. EMD 121974 in Treating Patients With Advanced Solid Tumors
3. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
4. BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
5. GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors
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