Status:
UNKNOWN
Docetaxel With or Without Low-dose, Short Course Sunitinib in Refractory Solid Tumors
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Solid Tumors
Breast Cancer
Eligibility:
FEMALE
18-99 years
Phase:
PHASE2
Brief Summary
This study aims to find out whether the effect of docetaxel chemotherapy may be improved by combining it with another anti-cancer drug called sunitinib, which stops blood vessels from growing (anti-an...
Detailed Description
This is a single-centre, phase II randomized study. Eligible patients will be randomized to docetaxel with or without intermittent sunitinib. A total of eighty patients with measurable tumor will be e...
Eligibility Criteria
Inclusion
- Age \>= 18 years.
- Histologic or cytologic diagnosis of carcinoma.
- Measurable tumor, defined as clinically palpable tumor with both diameters 2.0cm or greater as measured by caliper, or radiologically measurable tumor on CT scan with the largest diameter \>= 1cm.
- Eastern Cooperative Oncology Group 0-1
- Estimated life expectancy of at least 12 weeks.
- Adequate organ function including the following:
- \- Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L Platelets \>= 100 x 109/L
- \- Hepatic: Bilirubin \<= 1.5 x upper limit of normal (ULN), ALT or AST \<= 2.5x ULN, (or \<=5x with liver metastases)
- \- Renal: Creatinine \<= 1.5x ULN
- Signed informed consent from patient or legal representative.
- Patients with reproductive potential must use an approved contraceptive method if appropriate (e.g., intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion
- Treatment within the last 28 days with any investigational drug.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Major surgery within 28 days of study drug administration.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Pregnancy.
- Breast feeding.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Active bleeding disorder or bleeding site.
- Non-healing wound.
- Poorly controlled diabetes mellitus.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Symptomatic brain metastasis.
- History of significant neurological or mental disorder, including seizures or dementia.
- Known history of systemic connective tissue diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis), vasculities (e.g., giant cell arteritis, Kawasaki disease, Wegener's granulomatosis, Churg-Strauss disease) or sickle cell disease.
- Known history of renal impairment, defined as a Glomerular Filtration Rate (GFR) of less than 30ml/minute.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01803503
Start Date
May 1 2013
End Date
April 1 2018
Last Update
June 22 2016
Active Locations (2)
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1
National University Hospital
Singapore, Singapore, Singapore, 119228
2
National University Hospital
Singapore, Singapore, 119074