Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer

NCT00087282 | Completed Phase 2

• 3 other identifiers: CDR0000373877MSKCC-04038NCI-6475
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with flavopiridol works in treating patients with advanced liver cancer.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; advanced adult primary liver cancer; recurrent adult primary liver cancer

Interventions

alvocidib DRUG

irinotecan hydrochloride DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

alvocidib; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Ghassan Abou-Alfa, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Gary K. Schwartz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: June 1, 2004
• Study Completion: July 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2005-05

Locations

US (1)