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DX-8951f in Treating Patients With Liver Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00004108
First received: December 10, 1999
Last updated: May 15, 2012
Last verified: May 2012

December 10, 1999
May 15, 2012
September 1999
April 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004108 on ClinicalTrials.gov Archive Site
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DX-8951f in Treating Patients With Liver Cancer
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hepatocellular Carcinoma

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Liver Cancer
Drug: exatecan mesylate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
April 2005
April 2005   (final data collection date for primary outcome measure)

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

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004108
CDR0000067329, DAIICHI-8951A-PRT016, MDA-ID-99145, MSKCC-99058, UCHSC-00891
Not Provided
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP