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

NCT00005997 | Terminated Phase 2 DMC

• 5 other identifiers: CWRU2299U01CA063200P30CA043703CWRU-2299NCI-96
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Patients are followed every 3 months.

Secondary Outcomes (1)

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

  Patients are followed every 3 months.

Interventions

becatecarin DRUG

Cohorts of 3-6 patients receive escalating doses of rebeccamycin analogue until the maximum tolerated dose (MTD) is determined.

Also known as: DEAE-rebeccamycin, rebeccamycin analogue, rebeccamycin analogue, tartrate salt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 19399502 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

becatecarin

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Afshin Dowlati, MD

  Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: April 1, 1999
• Primary Completion: April 1, 2005
• Study Completion: November 1, 2005
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (3)