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Current Clinic Trials in Hobart

SORCE  PROTOCOL SUMMARY

Multi-centre randomised phase III double-blind placebo-controlled study examining the efficacy and tolerability of sorafenib (Nexavar) in patients with resected (total or partial) primary renal cell carcinoma (RCC) at high or intermediate risk or relapse. Patients will be randomised to one of three treatment arms in the ratio 2:3:3.

Patients population
Patients who have had an RCC resected are eligible for randomisation into SORCE providing they are at intermediate or high risk of relapse (Leibovich intermediate score 3-5, high score 6-11) and satisfy the inclusion/exclusion criteria.

Overview of Study Design:
Patients will be randomly assigned to 3 years of placebo (Arm A), 1 year sorafenib followed by 2 years placebo (Arm B) or 3 years sorafenib (Arm C). Sorafenib will be given at 400 mg po (per oral) bd doses. Patients with disease progression who progress on Arms A or B within 3 years of start of treatment whilst on placebo will be offered compassionate use of sorafenib at the standard dose of 400 mg po bd until further progression/toxicity. The duration of treatment for all arms during the double-blind stage is a maximum of 3 years.

Trial aims
The first question is whether at least one year of treatment with sorafenib increases DFS (disease-free survival) compared with placebo.
The second question is about the duration of sorafenib and whether three years of treatment increases DFS compared to one year.

Leibovich

Pathological T category of primary tumour(TNM 2002)

pT1a

0

 

pT1b

2

 

pT2

3

 

pT3a-4

4

Regional lymph node status (TNM 2002)

pNx or pN0

0

 

pN1 or pN2

2

Tumour size

<10cms

0

 

10cms or more

1

Nuclear grade

1 or 2

0

 

3

1

 

4

3

Histological tumour necrosis

No

0

 

Yes

1

Application of the scoring system to define risk groups: 0-2 Low risk, 3-5 Intermediate risk, 6 or more High risk

EVERSUN PROTOCOL SUMMARY

A phase 2 trial of EVERolimus alternating with SUNitinib as first line therapy for advanced renal cell carcinoma

Study aim
To determine if a regimen of alternating sunitinib and everolimus has sufficient activity to warrant further evaluation in a phase 3 trial as first line therapy for advanced renal cell carcinoma (RCC).

Study population
Patients starting first line systemic therapy for advanced RCC.

Study treatment
12-week cycles consisting of 4 weeks on sunitinib 50mg daily, then 2 weeks rest, then 5 weeks on everolimus 10 mg daily, then 1 week rest. Treatment is continued until progression or prohibitive toxicity is documented on both drugs

Millenium C21004 PROTOCOL SUMMARY

Study Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

Primary Objectives:
To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)
To determine if orteronel plus prednisone improves overall survival (OS)

Overview of Study Design:
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy naïve, metastatic, castration-resistant prostate cancer (mCRPC). Patients in the 2 treatment groups will receive blinded orteronel (or placebo) in addition to open-label prednisone and (GnRH) analogue therapy. Patients who have undergone orchiectomy and have a testosterone concentration of < 50 ng/dL may participate in the study without prior or ongoing concomitant GnRH analogue treatment.

Study Population:
Men at least 18 years of age who have histologically or cytologically confirmed adenocarcinoma of the prostate and documented progressive metastatic disease, based on either radiographic or PSA criteria, despite castrate levels of testosterone (< 50 ng/dL). Patients must have either absence of pain or pain not requiring opioid analgesia in the 2 weeks prior to randomization.

Millenium C21005 PROTOCOL SUMMARY

Study Title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed Following Docetaxel-based Therapy.

Primary Objective:
To determine if orteronel plus prednisone improves overall survival (OS)

Overview of Study Design:
This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone, compared with placebo plus prednisone, in men with metastatic, castration-resistant prostate cancer (mCRPC). (GnRH) analogue therapy will be continued unless the patient is surgically castrate. Patients must have evidence of disease progression during or after a minimum of 6 standard cycles (75 mg/m2/cycle) of docetaxel, or a total of ≥ 450 mg/m2. Patients who were clearly intolerant to docetaxel before receiving ≥ 450 mg/m2 are also eligible if they have received at least 3 standard cycles or ≥ 225 mg/m2 as local standard of care and meet the other study entry criteria.

Study Population:
Men at least 18 years of age who have histologically confirmed or cytologically confirmed adenocarcinoma of the prostate that has progressed following 1 to 2 prior cytotoxic chemotherapies, at least 1 of which must have included docetaxel therapy. Patients can be symptomatic or asymptomatic.

RAVES – RADIOTHERAPY ADJUVANT VERSUS EARLY SALVAGE

A PHASE III MULTI-CENTRE RANDOMISED TRIAL COMPARING ADJUVANT RADIOTHERAPY (RT) WITH SURVEILLANCE AND EARLY SALVAGE RT IN PATIENTS WITH POSITIVE MARGINS OR EXTRAPROSTATIC DISEASE FOLLOWING RADICAL PROSTATECTOMY

Primary Objective:
Biochemical failure (bF): PSA ≥ 0.40 ng/ml and rising following RT

Overview of Study Design:
This is a phase III multicentre randomised controlled trial. Eligible patients are randomised to either:

Arm 1: Standard arm
_ Adjuvant RT (ART) commenced within 4 months of RP.
_ 64 Gy in 32 fractions to the prostate bed, or

Arm 2: Experimental arm)
_ Active surveillance with early salvage RT (SRT)
_ 64 Gy in 32 fractions to the prostate bed _ Trigger for SRT is PSA level ≥ 0.20 ng/ml. RT should commence as soon as possible (no later than 4 months) following the first PSA measurement ≥ 0.20 ng/mL.

Study Population:
Men at least 18 years of age who have had a radical prostatectomy for histologically confirmed adenocarcinoma of the prostate and who have at least one of the following risk factors - Positive margins or pT3a or pT3b

CHEMO AND COGNITION

Cognitive Function and Treatment for Testicular Cancer
The primary outcome measure for this study is change in patient cognition from baseline assessments over the period of treatment and follow-up as assessed by the standardised, computerised measure CogHealth.

Overview of Study Design:
This is a national, multi-centre, observational study using a mixed between-within subjects design that will recruit about 154 testicular cancer patients over a period of 2 years.

Study population: Men being treated and followed for testicular cancer, with approximately half having chemotherapy and half having surgery alone.

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