Advanced or metastatic solid tumours that are refractory to standard therapy or for which no curative standard therapy exists and for which paclitaxel plus carboplatin is appropriate palliative chemotherapy. MedDRA version: 8.1 Level: LLT Classification code 10049280 Term: Solid tumour
Conditions
Interventions
Product Name: REOLYSIN
Pharmaceutical Form: Solution for infusion
Trade Name: Paclitaxel 6mg/mL concentrate for solution for infusion
Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for sol
Sponsors
Oncolytics Biotech Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient MUST: 1.Phase I: Have histologically proven advanced or loco-regionally advanced cancer, including head/neck cancer, which is not amenable to curative therapy refractory to standard therapy or for which no curative standard therapy exists and for which paclitaxel or carboplatin is appropriate palliative chemotherapy. Previous malignancy or those with 2 malignancies that are active are eligible. The latter are eligible provided it is reasonable to treat both malignancies with a platinum and taxane. Phase II: Patients with advanced or metastatic head/neck cancer that are refractory to standard therapy or for which no curative standard therapy exists. 2.Have evidence of measurable or evaluable disease. 3.Have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade =1. Surgery (except biopsies) must have occurred at least 28 Days prior to study enrolment. 4.Be at least 18 years of age. 5.Have received NO chemotherapy, radiotherapy, immunotherapy and NO hormonotherapy within 28 Days prior to receiving study drug; patients may continue to receive LHRH analogue therapy for prostate cancer if they have rising PSA. 6.Have an ECOG Performance Score of =2. 7.Have a life expectancy of at least 3 months. 8.Have baseline laboratory results as follows: oAbsolute neutrophil count (ANC) = 1.5 x 109 [SI units 109/L] oPlatelets = 100 x109 [SI units 109/L] (without platelet transfusion) oHaemoglobin = 9.0 g/dL [SI units gm/L] (with or without RBC transfusion) oSerum creatinine = 1.5 x upper limit of normal (ULN) oBilirubin = 1.5 x ULN oAST/ALT = 2.5 x ULN oNegative pregnancy test for females of childbearing potential. 9.Have signed an informed consent indicating that the patient is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. 10.Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: No patient may: 1.Receive concurrent therapy with any other investigational anticancer agent while on study (except patients with rising PSA who may continue on LHRH analogue therapy). 2.Have known brain metastasis(es). Such a patient must be excluded from this clinical trial because of their poor prognosis and because of frequent development of progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients who have had treated cerebral metastases that have been stable for 6 months are eligible 3.Be on immunosuppressive therapy or have known HIV infection or active hepatitis B or C. 4.Be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception. 5.Have clinically significant cardiac disease (New York Heart Association, Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris, myocardial infarction 1 year prior to study entry, or grade 2 or higher compromised left ventricular ejection fraction. 6.Have dementia or altered mental status that would prohibit informed consent. 7.Have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I : To determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of REOLYSIN when administered in combination with paclitaxel and carboplatin. In the case of no dose limiting toxicity occurring, the trial will be stopped when dose escalation of REOLYSIN reaches 3 x 1010 daily x 5. To recommend dose and schedule for future investigation Phase II: To measure tumour responses and duration of response, and describe any evidence of antitumour activity (CR, PR, CR+PR, CR+PR +SD). ;Secondary Objective: Phase I: To evaluate the humoral and cellular immune response to reovirus when given with paclitaxel and carboplatin To evaluate pharmacokinetics of paclitaxel and carboplatin when combined with REOLYSIN. To measure tumor responses and duration of response, and describe any evidence of antitumor activity To assess any extent of ‘shedding’ of virus from patients Phase II: To determine the safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head/neck cancer. ;Primary end point(s): Phase I: Dose limiting toxicity (DLT) which is used to define maximum tolerated dose (MTD) and recommended Phase I/II dose. Safety profile of REOLYSIN when administered in combination with paclitaxel and carboplatin. Phase II: Any evidence of antitumour activity (CR, PR, CR+PR, CR+PR +SD) | — |
Countries
United Kingdom
Outcome results
None listed