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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00005997

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer	Drug: becatecarin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers

Study Start Date :

Apr 1, 1999

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Determine the response rate in patients with advanced hepatobiliary carcinoma treated with rebeccamycin analogue. [Patients are followed every 3 months.]

Secondary Outcome Measures

Assess the toxicity associated with this drug in this patient population. [Patients are followed every 3 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
3	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15213