Albendazole (oral) phase I
- Conditions
- Cancer - Biliary tree (gall bladder and bile duct)Cancer refractory to conventional treatments
- Registration Number
- ACTRN12606000078550
- Lead Sponsor
- St George Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
1. Histologically or cytologically proven advanced or metastatic cancer2. Patients must have measurable (by imaging studies such as CT but not bone scan) or evaluable disease 3. Refractory to conventional treatments 4. A maximum of two previous systemic myelosuppressive chemotherapy regimens.5. Eastern Co-operative Oncology Group score (ECOG) 0-3 performance status.6. Patients with previously treated CNS (central nervous system) metastases are eligible, provided there is no clinical or radiological evidence of on-going CNS disease progression.7. Patients must have recovered from the reversible side effects of prior therapy.8. At least 3 weeks since prior chemotherapy (at least 6 weeks for agents known to be toxic to stem cells such as nitrosoureas, melphalan, or mitomycin).9. At least 2 weeks since any prior radiotherapy. No more than 25% of bone marrow may have been irradiated in the past.10. Patients of all races and ethnic backgrounds are eligible.11. Adequate Haematological function12. Absolute neutrophils > 1,500/mm3, platelets > 100,000/mm3, 13. bilirubin < 2x upper limit normal 14. Alanine amino transferase/aspartate amino transferase < 10 x upper limit of normal, 15. Calculated creatinine clearance > 60 mls/min.
1. Patients with unresolved ongoing infection requiring treatment.2. Decompensated liver disease with non malignant ascites or coagulopathy or encephalopathy3. Severe comorbidity at the discretion of the investigators4. Pregnancy or breast feeding mothers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose. No further dose increase will occur once the maximum tolerated dose is determined.[The maximum tolerated dose will be defined as being one dose level below that at which a dose limiting toxicity appeared in 33% of a single cohort.]
- Secondary Outcome Measures
Name Time Method 1. To determine pharmacokinetics and safety profile.[Pharmacokinetics are measured during cycle 1. Safety is monitored through weekly visits to clinic where adverse events are identified.];2. To determine preliminary efficacy through weekly measurement of relevant tumour markers.[]