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Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
becatecarin
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring localized unresectable adult primary liver cancer, advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, adult primary cholangiocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery Gall bladder carcinoma Cholangiocarcinoma Carcinoma of the ampulla Hepatocellular carcinoma (eligible for cohort II only) Measurable disease 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

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

Outcomes

Primary Outcome Measures

Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.

Secondary Outcome Measures

Assess the toxicity associated with this drug in this patient population.

Full Information

First Posted
July 5, 2000
Last Updated
June 9, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005997
Brief Title
Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer
Official Title
Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
slow accrual for Cohort II
Study Start Date
April 1999 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 rebeccamycin analogue in treating patients who have advanced liver and/or biliary cancer.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
Keywords
localized unresectable adult primary liver cancer, advanced adult primary liver cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer, adult primary hepatocellular carcinoma, cholangiocarcinoma of the gallbladder, cholangiocarcinoma of the extrahepatic bile duct, adult primary cholangiocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
becatecarin
Other Intervention Name(s)
DEAE-rebeccamycin, rebeccamycin analogue, rebeccamycin analogue, tartrate salt
Intervention Description
Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.
Primary Outcome Measure Information:
Title
Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue.
Time Frame
Patients are followed every 3 months.
Secondary Outcome Measure Information:
Title
Assess the toxicity associated with this drug in this patient population.
Time Frame
Patients are followed every 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of advanced hepatobiliary carcinoma not amenable to conventional surgery Gall bladder carcinoma Cholangiocarcinoma Carcinoma of the ampulla Hepatocellular carcinoma (eligible for cohort II only) Measurable disease 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Dowlati, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19399502
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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Rebeccamycin Analogue in Treating Patients With Advanced Liver and/or Biliary Cancer

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