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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004108 |
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.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: exatecan mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hepatocellular Carcinoma |
Study Start Date: | September 1999 |
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Colorado | |
University of Colorado Cancer Center | |
Denver, Colorado, United States, 80262 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Texas | |
Cancer Therapy & Research Center | |
San Antonio, Texas, United States, 78229 | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Robert L. DeJager, MD, FACP | Daiichi Sankyo Inc. |
Study ID Numbers: | CDR0000067329, DAIICHI-8951A-PRT016, MDA-ID-99145, MSKCC-99058, UCHSC-00891 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004108 History of Changes |
Health Authority: | United States: Federal Government |
localized resectable adult primary liver cancer localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular DX 8951 Recurrence Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Carcinoma, Hepatocellular Enzyme Inhibitors DX 8951 Pharmacologic Actions |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |