Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

001352

ACTR Number:

ACTRN12606000372583

Trial Status:

Registered

Date Submitted:

28/07/2004

Date Registered:

28/07/2004

Page 1

Public title:

A study evaluating the role of docetaxel (Taxotere) in combination with thalidomide in men with hormone refractory prostate cancer

ANZCTR registration title:

A feasibility and efficacy study, evaluating the prostate specific antigen (PSA) response, of taxotere/prednisone in combination with thalidomide in hormone refractory prostate cancer

Secondary ID 1:

National Clinical Trials Registry: NCTR588

Secondary ID 2:

Therapeutic Goods Administration (TGA): TGA 2004/172

UTN:

Trial acronym:

ProTat

Page 2
Health condition(s) or problem(s) studied:
Prostate cancer

Cancer	Prostate
Condition category:	Condition code:

Page 3

Description of intervention(s) / exposure:

All patients will receive treatment with docetaxel 75 mg/msquared intravenously every 3 weeks (1 cycle). On day 1 patients will commence a daily dose of prednisone 10 mg orally and a 200 mg oral dose of thalidomide given daily. Prophylactic enoxaparin at a dose of 40 mg subcutaneous will be administered daily. Patients will continue to receive treatment until disease progression, patient intolerance or withdraw of consent. Maximum number of cycles is 10. After study treatment discontinuation, patients will be treated by their physicians as determined by usual practice and followed for survival.

Intervention code:

Treatment: drugs

Comparator / control treatment:

Control group:

Historical

Page 4
Primary outcome 1:	1. PSA prostate specific antigen.
Timepoint:	Measured at baseline and 3 weekly intervals
Primary outcome 2:	2. Tumour lesion assessment.
Timepoint:	Measured after every second cycle for those patients with measurable disease
Primary outcome 3:	3. Progression free survival.
Timepoint:	Measured form registration to documented evidence of progression
Primary outcome 4:	4. Overall survival.
Timepoint:	Measured from registration to date of death
Secondary outcome 1:	1. Toxicity
Timepoint:	Measured at commencement of each cycle.
Secondary outcome 2:	2. Quality of life
Timepoint:	Measured at each cycle.

Page 5

Key inclusion criteria:

1. Histologically/cytologically proven prostate adenocarcinoma2. ALl patients are males, aged 18 years or more and must have prostate adenocarcinoma that is responsive or refractory to hormone therpay.3. Prior treatment with crticosteroids is allowed.4. life expectancy greater or equal to 3 months.5. prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery.6. ECOG 0-27. Informed consent signed

Minimum Age:

18 Years

Maximum Age:

Not stated

Gender:

Males

Healthy volunteers?

Key exclusion criteria:

1. Prior cytotoxic chemotherapy (except monotherapy with estramustine)2. prior isotope therapy3. prior radiotherapy to >25% of bone marrow (whole pelvic radiation is not allowed)4. known brain leptomeningeal involvement.5. Other malignancy6. Uncontrolled medical condition7. Prior Deep venous thrombosis or pulmonary embolism

Page 6

Study type:

Interventional

Purpose of the study:

Educational / counselling / training

Allocation to intervention:

Nonrandomised trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):

Masking / blinding:

Open (masking not used)

Assignment:

Single group

Other design features (specify):

Type of endpoint(s):

Safety/efficacy

Page 7

Phase

Phase 2

Anticipated or actual date of first participant enrolement:

1/02/2004

Target sample size:

Recruitment status:

Closed: follow-up continuing

Page 8

Funding source 1:

Commercial sector/Industry

Name:

Educational grant from Sanofi Aventis

Address:

Country:

Australia

Funding source 2:

Commercial sector/Industry

Name:

Educational grant from Pharmion

Address:

Country:

Funding source 3:

Charities/Societies/Foundations

Name:

Cancer Trials NSW

Address:

Country:

Australia

Primary sponsor:

Hospital

Name:

Royal North Shore Hospital

Address:

Country:

Australia

Secondary sponsor:

None

Name:

Nil

Address:

Country:

Other collaborator:

Page 9

Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name 1:

Royal North Shore Hospital

Address:

Country:

Australia

Date of approval:

15/03/2004

HREC Number:

0402-042M

Ethics Committee name 2:

Sydney Haematology Oncology Clinics

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 3:

Border Medical Oncology

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 4:

Lismore Base Hospital

Address:

Country:

Australia

Date of approval:

HREC Number:

Ethics Committee name 5:

Port Macquarie Base Hospital

Address:

Country:

Australia

Date of approval:

HREC Number:

Countries of recruitment:

Australia

Brief summary:

The ProTaT trial is a phase II trial evaluating the safety and activity of the combination of docetaxel (Taxotere), prednisone and Thalidomide in men with metastatic hormone refractory prostae cancer. The hypothesis is that the combination of a standard systemic therapy, docetaxel, with and antiangiogenic agent may improve the response rate in patients with this disease.

Trial website:

Presentations / publication list:

Page 10

Contact person for public queries

Name:

Sally McCowatt

Address:

Oncology Clinical Trials Unit Royal North Shore Hospital St Leonards Sydney NSW

Country:

Australia

Tel:

+61 2 99265049

Fax:

+61 2 94821341

Email:

smccowatt@nsccahs.gov.au

Contact person for scientific queries

Name:

Dr Gavin Marx

Address:

11/49 Plamerston rd Hornsby NSW 2077

Country:

Australia

Tel:

+ 61 2 94765844

Fax:

+ 61 2 94821341

Email:

gmarx@shoc.com.au

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

Page 1

Page 2

Page 3

Page 4

Page 5

Page 6

Page 7

Page 8

Page 9

Page 10