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A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma Clinical research trials and A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma. A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma  A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma
A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma
For Condition: Lymphoma,Neoplasm,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a dosage escalation study to estimate the maximum tolerated dose of paclitaxel and carboxyamidotriazole combination chemotherapy. Groups of 3 to 6 patients receive various doses and schedules of oral carboxyamidotriazole followed by a single 3-hour intravenous infusion of paclitaxel. Patients are re-treated every 21 days until 2 courses beyond complete response or until disease progression or unacceptable toxicity. Patients who develop neutropenic fever receive granulocyte colony-stimulating factor on subsequent courses.
Details: A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three weekly paclitaxel.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All patients with histologically determined solid tumors or lymphomas will be eligible according to the criteria below: Tumor slides must be reviewed in the laboratory of Pathology and demonstrated malignancy. Patients must be ECOG performance status of 2. Patients must have failed therapy of proven efficacy for the disease. Patients with metastatic melanoma, non-small cell lung cancer, renal cell carcinoma may be eligible without receiving prior therapy. Patients must have evidence of adequate major organ function: WBC 3000 cells/mm(3); Hct 27; Platelet count 1000,000/mm(3); Serum creatinine 1.5 mg/dl or creatinine clearance 45 cc/mm, and unobstructed kidneys; Liver function tests within 2x upper limit of normal and normal total serum bilirubin. No current cardiac conduction defects requiring antiarrhythmic therapy. No evidence of myocardial damage or ischemia within the preceeding 6 months. No brain metastases (Primary brain cancers may be eligible). Patients may not have greater than grade I neuropathy with the exception of fixed deficits in patients with primary brain cancers. Patients must have measurable or evaluable disease which is demonstrated by physical examination or radiographic evaluation within 15 days of initiation of therapy. Patients with marker only disease are not eligible with the exception of prostate cancer patients with elevated PSA. Patients must be off prior chemotherapy, hormonal therapy, radiation therapy, or biological therapy for at least 4 weeks prior to initiation of treatment. Patients who are receiving mitomycin, nitrosoureas, or carboplatin must be 6 weeks from the last administration of chemotherapy. All patients of child-bearing capability will be required to use contraception during therapy and for 2 months after completion of therapy. Pregnant and lactating patients will be excluded. Patients must have a life expectancy of at least 3 months. Patients must be able to give informed consent. Patients must be older than 18 years. EXCLUSION CRITERIA: Patients may not take concurrent corticosteroids above physiologic replacement levels, imidazole anti-mycotic agents (ketoconazole, fluconazole, or other members of that family). Patients who have received paclitaxel in the past and have progressed on paclitaxel or within 6 months of after completion of paclitaxel administration will be ineligible. Patients who received CAI in the past and have progressed on CAI or within 6 months of completion of CAI administration will be ineligible. Patients may not have concurrent infections and must be at least 1 week off antibiotic therapy before beginning therapy. Patients may remain on suppressive antibiotics are required with the exception of imidazole antifungal agents such as ketoconazole. Patients with abnormal coagulation parameters may be considered ineligible at the investigator's discretion. Patients with PT or PTT greater than 1.25 x ULN or taking anti-coagulants other than 1mg coumadin per day for line prophylaxis will be ineligible. Patients may not have evidence of bleeding such as guiaic positive stool. Patients who are HIV positive will not be eligible for this protocol. HIV testing will be required of all patients. A separate informed consent will be provided and discussed with patients.
Total Enrollment: 70
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Virginia Kwitkowski 3014025640
Additional Information:
Study ID Numbers: 950015; 95-C-0015
Study Start Date: October 19, 1994
Record last reviewed: August 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001423
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A Phase I Study of the Combination of Continuous Daily CAI and Intermittent Paclitaxel in Adult Patients with Refractory Cancers or Lymphoma
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