Status:
COMPLETED
Sirolimus and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. So...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of sirolimus used in combination with bevacizumab in patients with unresectable hepatocellular carcinoma. * Determine the toxicity profile ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Histologically confirmed unresectable hepatocellular carcinoma, meeting all of the following criteria:
- Failed 0-2 lines of chemotherapy
- Child-Pugh class A or B for liver cirrhosis
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan
- No known brain metastases
- Bone metastases allowed provided other measurable disease is present
- Healthy participant
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 70-100%
- Life expectancy \> 3 months
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- AST and ALT ≤ 5 times ULN
- Creatinine normal
- PTT \< 1.5 times ULN
- Fasting serum cholesterol ≤ 350 mg/dL
- Triglycerides ≤ 300 mg/dL
- Proteinuria \< 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection
- No history of allergic reactions to compounds of similar chemical or biologic composition to sirolimus or bevacizumab
- No prior thromboembolic disease that may result in bleeding or clotting problems related to use of bevacizumab including, but not limited to, the following:
- Esophageal varices
- Bleeding disorders
- Deep vein thromboses
- No history of hematemesis or hemoptysis
- No other uncontrolled illness including, but not limited to, the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would preclude study participation
- No HIV positivity
- Able to take oral medications
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and during the course of study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 28 days since prior surgery and recovered
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent traditional Chinese medicine(s)
- No concurrent long term anticoagulation with heparin or warfarin
- Concurrent prophylactic low-dose acetylsalicylic acid for patients at risk of an arterial thromboembolic event allowed
- Hepatitis B carriers must be on lamivudine during and for 6 months after completion of study treatment
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00467194
Start Date
December 1 2006
Last Update
June 17 2013
Active Locations (2)
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1
National Cancer Centre - Singapore
Singapore, Singapore, 169610
2
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 308433