SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer

Phase 2

Withdrawn

• Conditions: Liver Cancer

• Registration Number: NCT00020774
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

RATIONALE: Drugs used in chemotherapy use 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: Randomized phase II trial to compare the effectiveness of SCH 66336 with or without gemcitabine followed by surgery with that of surgery alone in treating patients who have primary liver cancer.

Detailed Description

OBJECTIVES: I. Determine the biologic activity and toxicity of neoadjuvant SCH 66336 with or without gemcitabine followed by surgical resection vs surgical resection alone in patients with resectable primary liver cancer.

OUTLINE: This is a randomized, open-label study. Patients are randomized to one of three treatment arms. Arm I: Patients receive neoadjuvant oral SCH 66336 twice daily for 14 days followed by surgical resection. Arm II: Patients receive neoadjuvant oral SCH 66336 twice daily for 14 days and gemcitabine IV over 30 minutes once weekly for 2 weeks followed by surgical resection. Arm III: Patients undergo surgical resection. Patients receive no neoadjuvant therapy prior to resection.

PROJECTED ACCRUAL: Approximately 30 patients (10 per treatment arm) will be accrued for this study.

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 2001-07-11
• Primary Completion: 2003-01
• Study First Submitted QC: 2004-04-12
• Study First Posted: 2004-04-13
• Status Verified: 2012-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically or cytologically confirmed resectable primary hepatocellular carcinoma or cholangiocarcinoma
• 18 and over
• Karnofsky 70-100%
• Hematopoietic: Absolute neutrophil count greater than 1,500/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin at least 9 g/dL Hepatic:
• Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater than 5 times ULN
• Albumin at least 2.5 g/dL INR less than 1.3 Renal:
• Creatinine no greater than 1.5 mg/dL
• Cardiovascular: QTc prolongation no greater than 440 msec Other:
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• At least 6 weeks since prior radiotherapy and recovered
• At least 6 weeks since prior surgery and recovered
• At least 6 weeks since prior systemic therapy and recovered

Exclusion Criteria

• metastatic disease outside of the liver
• pregnant or nursing
• malabsorption or other gastrointestinal (GI) condition that would preclude ability to take oral medication and/or GI absorption (e.g., partial small bowel obstruction)
• non-malignant systemic disease that would preclude study
• active uncontrolled infection No grade II nausea or grade I vomiting despite antiemetic medication
• concurrent immunotherapy Chemotherapy: No other concurrent chemotherapy
• concurrent hormonal therapy including estrogen therapy
• concurrent oral contraceptives or other hormonal methods Concurrent megestrol acetate allowed
• concurrent corticosteroids (except for nausea/vomiting during gemcitabine administration)
• concurrent CYP3A4 inhibitors or inducers including: Azoles (e.g., itraconazole, clotrimazole, fluconazole, or ketoconazole) Macrolide antibiotics (e.g., azithromycin, clarithromycin, or erythromycin) Cyclosporine Grapefruit Antiepileptic medication (e.g., phenytoin, carbamazepine, or phenobarbital) Antibiotics for tuberculosis (e.g., rifampin or isoniazid)
• concurrent HIV protease inhibitors (e.g., amprenavir, ritonavir, or saquinavir mesylate)
• concurrent cisapride
• other concurrent investigational therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified