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| Tracking Information | |||||
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| First Received Date ICMJE | December 10, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | September 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004108 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | DX-8951f in Treating Patients With Liver Cancer | ||||
| Official Title ICMJE | A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hepatocellular Carcinoma | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Liver Cancer | ||||
| Intervention ICMJE | Drug: exatecan mesylate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 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 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 Endocrine therapy: Not specified 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 |
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004108 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067329, DAIICHI-8951A-PRT016, MDA-ID-99145, MSKCC-99058, UCHSC-00891 | ||||
| Study Sponsor ICMJE | Daiichi Sankyo Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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