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A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma 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 Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma Clinical research trials and A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma 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 Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma. A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma 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 Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma 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 Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma  A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
For Condition: Hepatocellular Carcinoma,Liver Cancer
Status: Recruiting
Sponsor(s): PhytoCeutica ,
Synopsis: Capecitabine is a chemotherapeutic that has been approved for use in breast and colorectal cancers. The advantages of capecitabine are that (1) it is an oral drug; and (2) it is less toxic than many other chemotherapeutics. In an off-label hepatocellular carcinoma (HCC) clinical study, the response rate with capecitabine was 13%. The botanical drug PHY906--currently manufactured pursuant to GMP standards and regulations--has been used in China for over 1800 years to treat gastrointestinal-related ailments. Recently, preclinial studies demonstrated that PHY906 potentiates the anti-tumor effect of capecitabine. This trial will evaluate the safety and efficacy of PHY906 in enhancing the anti-tumor effects of capecitabine.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Men or women 18 to 80 years of age with a histologic or cytologic diagnosis of HCC. - All patients previously exposed to any prior anticancer treatments must have clear evidence of progressive disease after the most recent treatment regimen (see Exclusion Criteria). - In the phase I (dose finding) and phase II (efficacy) portions of the study, patients may either have had no prior chemotherapy (chemotherapy naive), no prior capecitabine chemotherapy, or have been refractory to--or relapsed from--no more than two prior systemically administered treatment regimens. (Chemoembolization is not regarded in this context as a systemically administered treatment regimen.) - All patients in both the phase I and phase II portions of this study must have at least one previously unirradiated, bidimensionally measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) scan of > 20 mm (if conventional CT scan) or more than or equal to 10 mm (if spiral CT scan). Triphasic spiral CT or MRI scans are preferred when such equipment is available. All CT scans should employ a “hepatoma protocol” image capture technique. - Patients with central nervous system (CNS) involvement will have had appropriate treatment and will be free of progressive neurological deficits in the 28 days prior to enrollment. - Patients with cirrhosis must have a Child-Pugh cirrhosis severity classification no greater than B. - Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2. - Life expectancy must be reasonably estimated to be > 12 weeks. - Women patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin [b-hCG]) within 2 weeks of starting the study; all patients should agree to use adequate non-estrogenic birth control methods, consistent with the institute’s standard form of contraception if conception is possible during the study. - Provide written informed consent prior to screening. Exclusion Criteria: - Patients with an estimated (Cockroft and Gault equation) to the power of 40 or calculated baseline creatinine clearance of 30-50 mL/min should have the starting dose of capecitabine reduced to 750 mg/m2 BID X 14 days; the dose of PHY906 remains unchanged. Patients with a baseline creatinine clearance of less than 30 mL/min should not be enrolled in this trial. - Patients with Child-Pugh cirrhosis severity classification of C. - Baseline abnormalities in hepatic tests (AST > 5.0 X study center upper limit of normal (ULN); ALT > 5.0 X study center ULN; albumin < 2.8 g/dL; international normalized ratio for prothrombin time (INR) > 1.5 X study center ULN; total bilirubin > 3.0 x study center ULN). - Baseline hemoglobin < 10.0 g/dL; total WBC < 2.0 X 10 to the power of 9/L; absolute neutrophil count (ANC) < 1.0 X 10 to the power of 9/L; or platelet count < 50.0 X 10 to the power of 9/L. - Patients who are pregnant or breastfeeding. - Any prior radiation therapy (other than small portals used for the palliation of isolated, symptomatic, osseous metastases) must have been completed more than 21 days before entry into the study and evaluable lesions must not have been included in the radiation portal. - Patients may be either treatment naive or have had previous anticancer treatment; if previously treated they may not have been exposed to capecitabine and no more than two prior systemically administered treatment regimens are allowed. It is required that all treatment be completed no less than 21 days prior to the patient being treated in this study. Chemoembolization or hepatic resection are not regarded as systemically administered treatment regimens. - Any treatment-related toxicity must have resolved within the 21 days prior to study entry. - Patients with previous or concurrent malignancy except for inactive non-melanoma skin cancer and/or in situ carcinoma of the cervix, or other solid tumor treated curatively and without evidence of recurrence within the last 3 years prior to study entry. - Patients with known, untreated brain metastases are ineligible for this trial. Patients with treated (irradiated) brain metastases are eligible if treatment was completed more than 28 days prior to study entry and if clinical neurologic function is stable. No patient, however, may enroll in this trial if they are taking phenytoin (Dilantin). Patients with carcinomatous meningitis, treated or untreated, are excluded from the study. - Patients with uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk. - Patients receiving warfarin (Coumadin), or any of the coumarin-type anticoagulants at any dose, even “mini-dose,” are excluded from this study because of a possible interference in their metabolism by capecitabine. - Known allergy or hypersensitivity to PHY906 or any of the components used in the PHY906 formulations, or to capecitabine.
Total Enrollment: 31
Location and Contact Information:
Weill Medical College *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler
VA Connecticut Cancer Center *Recruiting*
West Haven, Connecticut, 06516
United States
Recruiting Shivaani Kummar 203-937-3421
City of Hope National Medical Center *Recruiting*
Duarte, California, 91010
United States
Recruiting Yun Yen 626-359-8111
Stanford Hospital and Clinics *Not yet recruiting*
Stanford, California, 94305
United States
Not yet recruiting Samuel So 650-498-6092
Additional Information:
Study ID Numbers: PHY906-2002-1;
Study Start Date: November 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076609
Other Liver Cancer Studies:
1. Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer
2. A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
3. Liver Perfusion for Patients with Inoperable Liver Cancer
4. Aminocamptothecin in Treating Patients With Advanced Cancer of the Peritoneal Cavity
Related Studies:
Other Liver Cancer Clinical Trials
Other Connecticut Clinical Trials
Other West Haven Clinical Trials
A Phase I/II Study of Botanical PHY906 Plus Capecitabine for Advanced Unresectable Hepatocellular Carcinoma
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