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Home > "E" Clinical Trials Conditions > Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients  Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients
Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients
For Condition: Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine the dose of capecitabine that can be given safely with epirubicin and carboplatin in adults with solid tumor cancers. Capecitabine is an anti-cancer drug that can be taken by mouth. In the body, it is converted to 5- fluorouracil (5-FU), an established anti-cancer drug. 5-FU can only be given by vein. Infusing 5-FU into a vein daily for several weeks produces fewer side effects than giving it as a quick push into the vein. Taking capecitabine by mouth is another way to give 5-FU daily. Epirubicin and/or carboplatin are used to treat various types of cancer, including bladder, breast, stomach, ovary, uterus, prostate, testis, small cell lung cancer and cancers of the head and neck. Capecitabine is used to treat breast cancer in patients who no longer respond to standard therapy. Although all three drugs used in this study are approved anti-cancer treatments, their use together as proposed in this study is experimental. Patients 18 years of age and older with solid tumor cancers for which 1) this treatment is a reasonable choice of therapy, 2) no standard therapy is available, or 3) standard therapies have not successfully controlled the cancer may be eligible for this study. Candidates will be screened with blood tests, imaging studies (X-rays, CT and MRI scans) to assess the extent of cancer and an evaluation of heart function. Participants will have a 24-hour urine test to check kidney function for determining carboplatin dose. They will receive at least two 28-day treatment cycles, as follows: epirubicin and carboplatin by vein on day 1 and capecitabine by mouth in two doses on days 2-5, 8-12 and 15-19 of each cycle. Patients whose tumors have shrunk or remained stable after these 8 weeks and who tolerate the drugs may continue the 28-day treatment cycles without a fixed stopping point. The first patients in the study will receive a low dose of capecitabine, which will be increased gradually in subsequent groups of 3 to 6 patients until the highest tolerated dose is determined. Additional patients will be treated with this dose along with set doses of epirubicin and carboplatin. Blood will be drawn at various times during the study to measure drug levels in the blood, check liver and kidney function and check blood counts. Imaging studies will be done about every 8 weeks to check the status of the cancer. Patients will keep a diary of their side effects. Additional tests that will be done for research purposes include: - DNA studies - DNA from white blood cells will be examined for genetic variations among patients that may influence their response (side effects) to the study drugs. - Bone marrow aspiration - Before chemotherapy is started, patients will have a small sample of bone marrow taken for microscopic study. About 1 teaspoonful of bone marrow will be withdrawn through a needle placed in the hipbone. The area will be numbed first to lessen the discomfort. - Tumor biopsy - Patients whose tumor can be sampled easily at low risk will have a small tissue sample removed under local anesthetic.
Details: Background: The combination of epirubicin, cisplatin and a 21-day infusion of 5-fluorouracil (5-FU) is an active regimen in a variety of cancers. More importantly, this regimen has shown superiority to the FAMTX regimen (control arm) in a Phase III trial in advanced esophageal/gastric cancer in terms of response rate, time to disease progression, and survival. To improve patient convenience, this study will substitute oral capecitabine for the 21-day infusion of 5-FU; to reduce the toxicity associated with cisplatin, carboplatin will be used instead. The major objective of this study is to determine the safety and feasibility of administering oral capecitabine in combination with fixed IV doses of carboplatin and epirubicin. Secondary objectives include pharmacokinetic analysis of both epirubicin and capecitabine and their metabolites, pharmacogenetic analysis of polymorphisms in the promoter region of the human thymidylate synthase gene and its correlation with TS expression, and molecular profiling of tumor tissue for determinants of sensitivity to carboplatin, capecitabine and epirubicin. Epirubicin 75 mg and carboplatin AUC 5 will each be given on day 1 of each cycle. Oral capecitabine will be given twice daily on days 2-5, 8-12, and 15-19 of each 28 day cycle. This schedule is supported by local clinical experience from an ongoing clinical trial showing improved patient tolerance for capecitabine when breaks are scheduled in the cycle. The starting daily dose of capecitabine will be 600 mg/m(2); if tolerated, the dose of capecitabine will be escalated in cohorts of patients. Dose adjustments for the study drugs will be made based on their individual tolerance. Patients will receive the initial week of therapy at NNMC-Bethesda to allow collection of research blood and tissue samples. Subsequent therapy may be given at either participating institution that is most convenient for the patient.
Eligibility:
Study Type: Interventional,�Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Cancer patients whose disease has progressed on standard therapy, including patients with locally advanced, but unresectable primary or recurrent solid tumors, or those with metastatic disease are eligible. Patients with previously untreated metastatic cancer for whom this regimen represents reasonable initial chemotherapy with palliative intent, such as metastatic gastric cancer, hepatobiliary cancer, or cancers for which no effective standard therapy exists, will also be eligible. Pathology will be reviewed to confirm the diagnosis of cancer. Measurable disease is preferred, but not required. Patients must have a performance Status of 0-2. Prior Treatment: (the following criteria should be met): Greater than 4 weeks should have elapsed since prior chemotherapy or immunotherapy, and the patient should have recovered from the toxicities associated with such therapy. If prior nitrosureas or mitomycin C have been given, at least 6 weeks should have elapsed. Two or more weeks should have elapsed since any radiotherapy, and the patient should have recovered from the toxicity associated with such therapy. If prior strontium therapy has been given, however, at least eight weeks should have elapsed. If a recent surgical procedure has been performed, the patient should have recovered from the surgery prior to entering this trial. Patients should have an absolute granulocyte count greater than or equal to 2000/microliters and a platelet count greater than or equal to 100,000/microliters. Patients should have adequate hepatic function as indicated by a serum bilirubin less than or equal to 1.5 mg/dL and AST(SGOT) and ALT(SGPT) levels less than or equal to 2.5 times the upper limits of normal. All patients should have adequate renal function as indicated by a serum creatinine less than or equal to 1.6 mg/dL. Patients must be willing to give a signed informed consent. Patients age must be greater than or equal to 18 years. EXCLUSION CRITERIA: Patients with potentially curative treatment options including surgery, radiation or chemoradiation, or combination chemotherapy are not eligible. Patients with leukemia and lymphoma are not eligible. Patients with serious concurrent medical illness which would jeopardize the ability of the patient to receive the chemotherapy program are not eligible. Patients with active infections requiring intravenous antibiotic therapy are not eligible until the infection has resolved. Patients who are HIV antibody positive and are receiving anti-retroviral therapyare not eligible. Patients with primary CNS malignancies and CNS metastatic disease are not eligible. Patients with a history of allergy to platinum compounds, mannitol, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy are not eligible. Patients with a prior history of unexpectedly severe intolerance to 5-fluorouracil, since such patients may also experience severe or life-threatening toxicity with capecitabine are not eligible. Patients with left ventricular ejection fraction less than 50 percent are not eligible. Patients with a prior exposure to doxorubicin at cumulative doses greater than 300 mg/m(2) are not eligible. Patients receiving cimetidine must discontinue its use prior to starting this protocol. Pregnant women or nursing mothers are not eligible for this study. Eligible patients of reproductive potential should use adequate contraception.
Total Enrollment: 45
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010172; 01-C-0172
Study Start Date: May 2, 2001
Record last reviewed: April 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015743
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Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients
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