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A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients Clinical research trials and A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients. A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients clinical trial. Test subjects typically receive the most expert healthcare available for their A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients  A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients
A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients
For Condition: Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The major objective of this amended study is to determine the safety and activity of administering capecitabine at the recommended Phase II dose in combination with a fixed dose of oxaliplatin in patients with colorectal and small bowel cancer (including appendiceal primaries). Secondary objectives are to assess the molecular profile of tumor tissue obtained prior to starting on study for determinants of sensitivity to oxaliplatin and capecitabine, and to measure any potential effect of capecitabine therapy on inhibition of thymidylate synthase. Oxaliplatin 130 mg/m(2) will be given as a 2 hr i.v. infusion once every three weeks. Capecitabine will start on day one after the oxaliplatin infusion, and 2400 mg/m(2) will be given in two divided doses daily for days 1-5 and 8-12 followed by a 9-day rest. Dose adjustments for both oxaliplatin and capecitabine within patients will be made based on their individual tolerance. Patients with stable or responsive disease will continue on therapy until evidence of disease progression provided they are willing and tolerate the treatment.
Details: The major objective of this amended study is to determine the safety and activity of administering capecitabine at the recommended Phase II dose in combination with a fixed dose of oxaliplatin in patients with colorectal and small bowel cancer (including appendiceal primaries). Secondary objectives are to assess the molecular profile of tumor tissue obtained prior to starting on study for determinants of sensitivity to oxaliplatin and capecitabine, and to measure any potential effect of capecitabine therapy on inhibition of thymidylate synthase. Oxaliplatin 130 mg/m(2) will be given as a 2 hr i.v. infusion once every three weeks. Capecitabine will start on day one after the oxaliplatin infusion, and 2400 mg/m(2) will be given in two divided doses daily for days 1-5 and 8-12 followed by a 9-day rest. Dose adjustments for both oxaliplatin and capecitabine within patients will be made based on their individual tolerance. Patients with stable or responsive disease will continue on therapy until evidence of disease progression provided they are willing and tolerate the treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have a histologically confirmed diagnosis of malignancy. Patients with adenocarcinoma arising in the colon, rectum, small bowel or appendix. Patients must not have received more than two prior systemic chemotherapy regimens for metastatic disease. Minimum Interval from Prior therapies: Patients should have recovered from toxicities associated with prior therapies before entering on this protocol. -Mitomycin C or nitrosoureas, Minimum Interval 6 weeks; -Eniluracil, Minimum Interval 8 weeks; -Suramin, Minimum Interval 3 months; -Other chemotherapy drugs, Minimum Interval 4 weeks; -Immunotherapies, Minimum Interval 4 weeks; -Sorivudine or brivudine (antiviral), Minimum Interval 4 weeks. At least two weeks should have elapsed since any prior radiotherapy, and the patient should have recovered from the toxicity associated with such therapy. If a recent surgical procedure has been performed, the patient should have recovered from the surgery prior to entering this trial. Measurable disease is required for this study Age greater than or equal to 18 years (no safety data is available for either oxaliplatin or capecitabine in pediatric patients). ECOG performance status of 0-2. Patients must have adequate organ and marrow function as defined below: -Leukocytes greater than or equal to 3,000/microliters -Absolute neutrophil count greater than or equal to 1,500/microliters -Platelets greater than or equal to 100,000/microliters -Total bilirubin within normal institutional limits -AST(SGOT)/ALT(SGPT) less than or equal to 2.5 times institutional upper limit of normal -Creatinine within normal institutional limits -Calculated creatinine clearance greater than 60 mL/min [Cockroft & Gault formula] Cockroft & Gault Formula for creatinine clearance: Males: [140 - age in years] x [body weight in kg] divided by [72] x serum creatinine in mg/dL] Females: 0.85 x [140 - age in years] x [body weight in kg] divided by [72] x serum creatinine in mg/dL] Patients must not have symptomatic sensory neuropathy nor clinical evidence of sensory neuropathy on physical exam. The effects of oxaliplatin and capecitabine on the developing human fetus at the recommended therapeutic doses are unknown. For this reason and because DNA alkylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: Patients undergoing therapy with other investigational agents. Patients with known brain metastases or leptomeningeal carcinomatosis should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other toxicities. History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. Patients with a prior history of marked intolerance to 5-fluorouracil, since such patients may also experience severe or life-threatening toxicity with capecitabine. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia, that might jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safety. Pregnant and nursing women are excluded from this study because oxaliplatin and capecitabine both have the potential for teratogenic or abortifacient effects. Because the major purpose of this trial is to determine the safety of combining oxaliplatin with capecitabline, HIV-positive patients are excluded from the study because of possible differences in sensitivity to the toxic side effects of chemotherapy. Because of a potentially fatal drug interaction between fluorouracil and the antiviral agents sorivudine or brivudine, patients must not receive either drug while receiving capecitabine. Patients who have experienced disease progression on prior capecitabine.
Total Enrollment: 106
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990117; 99-C-0117
Study Start Date: May 29, 1999
Record last reviewed: May 3, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001817
Other Neoplasm Studies:
1. Clinical Evaluation of a Laser Heated, Fiberoptic-Coupled Radiation Dose Verification System
2. A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients
3. Treatment of Patients with Cancer with Genetically Modified Salmonella Typhimurium Bacteria
4. Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Kidney Dysfunction
5. gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma
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A Pilot Study of Oxaliplatin in Combination with Capecitabine in Adult Cancer Patients
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