Using OCZ103-OS in Patients With Unresectable and Locally Recurrent or Metastatic Colorectal Canc… (NCT01378143) | Clinical Trial Compass
CompletedPhase 2
Using OCZ103-OS in Patients With Unresectable and Locally Recurrent or Metastatic Colorectal Cancer Undergoing Standard Chemotherapy
Canada53 participantsStarted 2011-03
Plain-language summary
The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS in combination with standard of care as a second line treatment in subjects with unresectable and locally recurrent or metastatic colorectal cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically or cytologically proven diagnosis of adenocarcinoma of the colon/rectum with evidence of (1) unresectable and, locally recurrent, or (2) metastatic disease.
✓. Failure of first-line therapy(5-Fu-based therapy +/- bevacizumab) for metastatic colorectal cancer.
✓. At least one (1) unidimensionally measurable lesion (on spiral CT scan).
✓. 18 years of age or older.
✓. ECOG performance status 0, 1 or 2.
✓. Serum aspartate transaminase (AST), serum alanine transaminase (ALT), serum alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN), or AST,ALT, ALP ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
✓. Total serum bilirubin ≤ 1.5 x ULN
✓. Lipase and amylase within normal limits or abnormal limits but deemed not clinically significant.
Exclusion criteria
✕. Systolic Blood Pressure \<100 mmHg (if deemed clinically significant by the treating physician).
✕. Uncontrolled diabetes, severe renal impairment or pancreatitis.
✕. Concomitant therapy with other investigational agents or participation in another clinical trial within 30 days prior to enrollment.
✕. Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval \> 450 msec for males or \> 470 msec for females or uncontrolled intercurrent illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia \< 50 bpm; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome).
✕. Concurrent use of drugs that could prolong QT interval (NB: pentamidine is known to induce torsades de pointes) (see Appendix II: List of drugs that could prolong QT interval / we also suggest that you refer to the following link: http://www.azcert.org/medical-pros/drug-lists/bycategory.cfm).
✕. Concurrent use of nephrotoxic drugs (depending on the medical health status of the patient and based on the judgment of the investigator), including but not limited to aminoglycosides, ampho B, foscarnet and cidofovir.
✕. Concurrent use of drugs such as Rifampine and Lamivudine, since these that may be associated with pancreatitis.