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Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers


Phase 2
18 Years
N/A
Not Enrolling
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer

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Trial Information

Phase II and Pharmacokinetic Trial of Rebeccamycin Analog in Hepatobiliary Cancers


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Patients are followed every 3 months.

Safety Issue:

No

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU2299

NCT ID:

NCT00005997

Start Date:

April 1999

Completion Date:

November 2005

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • 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
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms

Name

Location
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294