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A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma


OBJECTIVES:

Primary

- Determine the time to progression in patients with advanced hepatocellular carcinoma
treated with irinotecan and flavopiridol.

Secondary

- Determine the response rate and overall survival in patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label, non-randomized study.

Patients receive irinotecan IV over 30 minutes and flavopiridol IV over 1 hour on days 1, 8,
15, and 22. Courses repeat every 42 days in the absence of disease progression or
unacceptable toxicity.

PROJECTED ACCRUAL: A total of 16-32 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed hepatocellular carcinoma

- Advanced disease

- Measurable disease

- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
OR ≥ 10 mm by spiral CT scan

- Prior local therapy (e.g., surgery, hepatic arterial embolization, radiofrequency
ablation, or cryoablation) allowed provided therapy was completed ≥ 8 weeks before
study entry AND ≥ 1 of the following conditions are met:

- Target lesion was not subjected to local therapy

- 25% increase in the size of target lesion within the field of prior local
therapy

- Lesions treated with external beam radiotherapy are not acceptable as
target lesions

- Child-Pugh class A or B status if liver cirrhosis is present

- Score 7 or 8 only

- No known brain metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3

- WBC ≥ 3,000/mm^3

Hepatic

- See Disease Characteristics

- AST and ALT ≤ 2.5 times upper limit of normal

- Bilirubin ≤ 1.5 mg/dL

Renal

- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No deep vein thrombosis within the past 6 months

- Patients maintained on anticoagulation therapy for an event that occurred more
than 6 months ago are eligible

- No myocardial infarction within the past 6 months

- No cardiac arrhythmia within the past 6 months

- Rate-controlled atrial fibrillation allowed if stable for at least 6 months

Pulmonary

- No pulmonary embolus within the past 6 months

- Patients maintained on anticoagulation therapy for an event that occurred more
than 6 months ago are eligible

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- No prior allergic reaction attributed to compounds of similar chemical or biological
composition to flavopiridol or irinotecan

- No clinically significant gastrointestinal bleeding requiring hospitalization within
the past month

- No active or ongoing infection

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

- No other malignancy within the past 3 years except carcinoma in situ of the cervix,
adequately treated basal cell skin cancer, or superficial bladder tumors [Ta, Tis, or
T1]

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior systemic biologic therapy

Chemotherapy

- No prior systemic chemotherapy for hepatocellular carcinoma

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

- No prior organ allograft

Other

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent vitamins, antioxidants, or herbal preparations and supplements

- Single-tablet multivitamin allowed

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ghassan Abou-Alfa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000373877

NCT ID:

NCT00087282

Start Date:

June 2004

Completion Date:

July 2006

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021