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Home > "D" Clinical Trials Conditions > DX-8951f in Treating Patients With Liver Cancer  DX-8951f in Treating Patients With Liver Cancer
DX-8951f in Treating Patients With Liver Cancer
For Condition: advanced adult primary liver cancer,localized resectable adult primary liver cancer,adult primary hepatocellular carcinoma,localized unresectable adult primary liver cancer,recurrent adult primary liver cancer
Status: No longer recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have liver cancer.
Details: OBJECTIVES: I. Evaluate the antitumor activity of DX-8951f in terms of antitumor response, response duration, and survival in patients with hepatocellular carcinoma. II. Assess the quantitative and qualitative toxicities of this treatment regimen in this patient population. III. Evaluate the pharmacokinetics of DX-8951 in plasma. PROTOCOL OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed hepatocellular carcinoma with or without evidence of unresectable extrahepatic metastasis; Previously untreated disease OR Progressive disease after first line chemotherapy - Bidimensionally measurable disease by CT scan, chest x-ray, or MRI of the abdomen - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy and recovered; No prior camptothecin analogues; No other concurrent chemotherapy - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: At least 4 weeks since prior major surgery and recovered; No concurrent surgery - Other: No other concurrent anticancer therapy; At least 4 weeks since prior investigational drugs (including analgesics or antiemetics); No other investigational drugs during or within 28 days after final dose of study drug --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 80,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; Albumin at least 2.8 g/dL SGOT/SGPT no greater than 5 times upper limit of normal (ULN); PT/INR no greater than 1.5 times ULN if not on coumadin therapy - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No active congestive heart failure; No uncontrolled angina; No myocardial infarction within the past 6 months - Other: No concurrent serious infection; No other life threatening illness; No overt psychosis or mental disability that would preclude informed consent; No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception 1 month prior to and during the study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
Cancer Therapy & Research Center
San Antonio, Texas, 78229
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067329; DAIICHI-8951A-PRT016,MDA-ID-99145,MSKCC-99058,UCHSC-00891
Study Start Date: September 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004108
Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
2. TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
3. Vaccine Therapy in Treating Patients With Liver Cancer
4. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
5. Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Related Studies:
Other localized unresectable adult primary liver cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
DX-8951f in Treating Patients With Liver Cancer
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