Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
NCT ID: NCT00005997
Last Updated: 2010-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
72 participants
INTERVENTIONAL
1999-04-30
2005-11-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.
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Detailed Description
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* Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
* Assess the toxicity associated with this drug in this patient population.
* Evaluate the survival of this patient population treated with this drug.
* Determine the pharmacokinetics of this drug in this patient population.
OUTLINE: This is a partial dose-escalation study.
Patients receive rebeccamycin analogue IV over 1 hour daily on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are assigned to 1 of 2 cohorts according to hepatic dysfunction. (Cohort I closed to accrual as of 11/1/03.)
* Cohort I (closed to accrual as of 11/1/03): Patients receive a fixed dose of rebeccamycin analogue.
* Cohort II: Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-37 months.
Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Interventions
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becatecarin
Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No known brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
Hepatic:
* Bilirubin less than 3 mg/dL
* Cohort I (closed to accrual as of 11/1/03)
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 2.5 times upper limit of normal (ULN)
* Cohort II
* Bilirubin greater than 1.5 mg/dL and less than 3 mg/dL OR
* Bilirubin no greater 1.5 mg/dL AND AST greater than 2.5 times ULN
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for cholangiocarcinoma or hepatobiliary carcinoma
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent combination antiviral therapy for HIV-positive patients
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Principal Investigators
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Afshin Dowlati, MD
Role: STUDY_CHAIR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Countries
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References
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Dowlati A, Posey J, Ramanathan RK, Rath L, Fu P, Chak A, Krishnamurthi S, Brell J, Ingalls S, Hoppel CL, Ivy P, Remick SC. Phase II and pharmacokinetic trial of rebeccamycin analog in advanced biliary cancers. Cancer Chemother Pharmacol. 2009 Dec;65(1):73-8. doi: 10.1007/s00280-009-1005-x. Epub 2009 Apr 28.
Dowlati A, Posey J, Ramanathan RK, et al.: Multicenter phase II and pharmacokinetic study of rebeccamycin analogue (RA) in advanced biliary cancers. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1070, 2003.
Other Identifiers
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CWRU-2299
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-96
Identifier Type: -
Identifier Source: secondary_id
CWRU2299
Identifier Type: -
Identifier Source: org_study_id
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